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DanEuph Regular Member
Joined: 17 Aug 2022 Posts: 24 Location: Wales, UK
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Posted: Thu May 23, 2024 4:44 am Post subject: The Legality and Safety of the Compression Training System |
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Hi all! I'm a sinner (euphonium player) but I thought this was a good place to stir up some conversation.
I recently got into a discussion on Facebook with someone selling the tool above. I'd never seen this before, so I was curious. After doing some investigation, this appears to be nothing more than a sphygmomanometer gauge, which is purchasable for $16 but being sold for $75 as part of the above "system."
My concerns however are not for the hustle, but for medical and legal reasons. You can't just take a class II medical device, slap a brand name on it, and then sell it for a completely different purpose. Repurposing a medical device like a sphygmomanometer (blood pressure cuff) for a new, non-medical intended use would have to undergo the Premarket Notification or 510(k) process by the FDA, and I can see nothing online which says this has been done. When I asked the seller, I was told to read the testimonials of trumpet players and then promptly blocked by the seller.
I'm happy to be proved wrong, of course! But if I'm right and approval hasn't been sought, then this device could potentially be dangerous for some people.
Thanks, |
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cbtj51 Heavyweight Member
Joined: 24 Nov 2015 Posts: 739 Location: SE US
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Posted: Thu May 23, 2024 5:16 am Post subject: |
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on 2nd thought...
Life is Short, find the Joy in it!
Mike _________________ '71 LA Benge 5X Bb
'72 LA Benge D/Eb
'76 Bach CL 229/25A C
‘92 Bach 37 Bb
'98 Getzen 895S Flugelhorn
'00 Bach 184 Cornet
'02 Yamaha 8335RGS
'16 Bach NY 7
'16 XO 1700RS Piccolo
Reeves 41 Rimmed Mouthpieces
Last edited by cbtj51 on Thu May 23, 2024 5:56 am; edited 1 time in total |
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JayKosta Heavyweight Member
Joined: 24 Dec 2018 Posts: 3380 Location: Endwell NY USA
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Posted: Thu May 23, 2024 5:23 am Post subject: Re: The Legality and Safety of the Compression Training Syst |
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I don't think the Premarket Notification process applies in this situation - the device is not being marketed or sold as a 'medical device' - but as an air pressure gauge, and is not intended to treat a medical condition.
see -
https://www.fda.gov/medical-devices/510k-clearances/medical-device-safety-and-510k-clearance-process
Similar to sale of medical scalpels for non-medical carving use.
And yes, improper use could be dangerous - but that is because of the user, not the device. _________________ Most Important Note ? - the next one !
KNOW (see) what the next note is BEFORE you have to play it.
PLAY the next note 'on time' and 'in rhythm'.
Oh ya, watch the conductor - they set what is 'on time'. |
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DanEuph Regular Member
Joined: 17 Aug 2022 Posts: 24 Location: Wales, UK
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Posted: Thu May 23, 2024 5:41 am Post subject: Re: The Legality and Safety of the Compression Training Syst |
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JayKosta wrote: | I don't think the Premarket Notification process applies in this situation - the device is not being marketed or sold as a 'medical device' - but as an air pressure gauge, and is not intended to treat a medical condition.
see -
https://www.fda.gov/medical-devices/510k-clearances/medical-device-safety-and-510k-clearance-process
Similar to sale of medical scalpels for non-medical carving use.
And yes, improper use could be dangerous - but that is because of the user, not the device. |
I get what you're saying, and I too explored this earlier as a potential loophole. While the intended use is now non-medical, the FDA takes the view that once a product meets the definition of a medical device based on its original intended use, it remains a regulated medical device even if remarketed for an alternate purpose. Simply renaming or rebranding it does not circumvent the need for proper FDA review and clearance when changing the intended use from its legally marketed medical purpose.
Also, improper use is a different issue, I'm talking about using the device the way the seller instructs, which hasn't been properly assessed and evaluated by a qualified authority. Using the device the "proper way" could still be harmful to some people. |
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JayKosta Heavyweight Member
Joined: 24 Dec 2018 Posts: 3380 Location: Endwell NY USA
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Posted: Thu May 23, 2024 5:53 am Post subject: Re: The Legality and Safety of the Compression Training Syst |
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DanEuph wrote: | ... While the intended use is now non-medical, the FDA takes the view that once a product meets the definition of a medical device based on its original intended use, it remains a regulated medical device even if remarketed for an alternate purpose. ... |
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I'd like to read about that, do you have any links to reliable sources?
And of course there's a difference between 'taking the view' and there being an actual regulation. _________________ Most Important Note ? - the next one !
KNOW (see) what the next note is BEFORE you have to play it.
PLAY the next note 'on time' and 'in rhythm'.
Oh ya, watch the conductor - they set what is 'on time'. |
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DanEuph Regular Member
Joined: 17 Aug 2022 Posts: 24 Location: Wales, UK
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DanEuph Regular Member
Joined: 17 Aug 2022 Posts: 24 Location: Wales, UK
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Posted: Thu May 23, 2024 6:11 am Post subject: Re: The Legality and Safety of the Compression Training Syst |
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JayKosta wrote: | DanEuph wrote: | ... While the intended use is now non-medical, the FDA takes the view that once a product meets the definition of a medical device based on its original intended use, it remains a regulated medical device even if remarketed for an alternate purpose. ... |
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I'd like to read about that, do you have any links to reliable sources?
And of course there's a difference between 'taking the view' and there being an actual regulation. |
Sorry, forgot one - https://www.topra.org/topra/topra_member/pdfs/CPD-May-2019-Medical-Devices-and-FDA.pdf |
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huntman10 Heavyweight Member
Joined: 30 Aug 2017 Posts: 726 Location: Texas South Plains
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Posted: Thu May 23, 2024 6:36 am Post subject: |
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As a confirmed member of the old fogey generation, and dues paying Medicare subpart whatever health services participant, I am "requested" to show up for annual testing. This last fall, as part of my respiratory exam, I was told to blow into just such a sphygmomanometer gauge. My wife says, "Oh, he has played trumpet for 60 years, he has no problem with that!" To which the technician responded *AHEM*, "I didn't know it could go THAT high!"
So I guess my point is that it does seem to be applied in just that medical usage. _________________ huntman10
Collector/Player of Fine (and not so fine) Brass Instruments including
Various Strads, Yammies, Al Hirt Courtois, Schilkes,
Selmer 25, Getzen Eternas, Kanstuls (920 Pic, CG)
Martin Custom Large Bore, Lots Olds!, Conns, etc. |
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kalijah Heavyweight Member
Joined: 06 Nov 2003 Posts: 3288 Location: Alabama
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Posted: Thu May 23, 2024 6:45 am Post subject: |
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It is a pressure gauge. The greatest pressure intended to be with the air trapped in the mouth, not lung exhalation pressure, which is likely perfectly safe. Holding the pressurized air with a mouthpiece rim placed is really a static "hold" isometric exercise.
Of course, this same exercise can be done with a "blocked" mouthpiece of any size or portion. (Even such as a Warburton top only).
The pressure could be measured in the mouth with a very small tube through the mouth corner to a pressure gauge or even electronic device. If one was interested in the pressure they are achieving. I don't think that knowing the pressure has any bearing on the benefit of the exercise.
Larry's misunderstanding is believing the tongues action "compresses" the air when also using lung air pressure. Which it does not.
I always felt he could have done this more effectively by just selling a .pdf and/or video course on the static exercises and include how to connect your own meter if you wish to track the pressures achieved. |
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DanEuph Regular Member
Joined: 17 Aug 2022 Posts: 24 Location: Wales, UK
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Posted: Thu May 23, 2024 7:22 am Post subject: |
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kalijah wrote: | It is a pressure gauge. The greatest pressure intended to be with the air trapped in the mouth, not lung exhalation pressure, which is likely perfectly safe. Holding the pressurized air with a mouthpiece rim placed is really a static "hold" isometric exercise.
Of course, this same exercise can be done with a "blocked" mouthpiece of any size or portion. (Even such as a Warburton top only).
The pressure could be measured in the mouth with a very small tube through the mouth corner to a pressure gauge or even electronic device. If one was interested in the pressure they are achieving. I don't think that knowing the pressure has any bearing on the benefit of the exercise.
Larry's misunderstanding is believing the tongues action "compresses" the air when also using lung air pressure. Which it does not.
I always felt he could have done this more effectively by just selling a .pdf and/or video course on the static exercises and include how to connect your own meter if you wish to track the pressures achieved. |
If people want to do this off their own backs then they can go for it. I have a five octave range on my instrument which happens very easily. I've practiced compression, sure, but with exercises on the instrument or recently with a pencil... I find compression is just the pinching power of the chops.
But, as i said, my issues aren't playing or concept related. My issues revolve around the legality of what's occurring here, and the safety concerns. There are people out there that this could be damaging for, and thanks to the lack of due diligence by the seller, there are no warnings or guidance for which sorts of conditions or underlying issues that could be exacerbated by usage of this device. |
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Rhondo Veteran Member
Joined: 22 Oct 2021 Posts: 339
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Posted: Thu May 23, 2024 7:55 am Post subject: |
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Why would the seller block you if all you were doing was asking a question? |
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DanEuph Regular Member
Joined: 17 Aug 2022 Posts: 24 Location: Wales, UK
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Posted: Thu May 23, 2024 8:04 am Post subject: |
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Rhondo wrote: | Why would the seller block you if all you were doing was asking a question? |
No idea! It was a British guy called Simon something. I mentioned the cheapness of the device and the substantial markup, asking what the reason was... Was met with several posts describing testimonials from players. Then I asked if they were FDA approved, and then the post got deleted and the guy blocked me.
Just write "no, but we're looking into it," or something! |
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kalijah Heavyweight Member
Joined: 06 Nov 2003 Posts: 3288 Location: Alabama
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Posted: Thu May 23, 2024 8:15 am Post subject: |
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Quote: | I've practiced compression, sure, but with exercises on the instrument or recently with a pencil... I find compression is just the pinching power of the chops |
You are referring to what is commonly understood to be lip-compression. This is not necessarily related to air compression by exhalation effort.
And I agree, one can easily do all the strength building required using Caruso Type exercises WHILE playing tones. And static gripping exercises can make for nice supplemental calisthenic work without exposing the lip to additional mp rim force. |
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astadler Veteran Member
Joined: 11 Feb 2014 Posts: 132 Location: Little Rock, AR
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Posted: Thu May 23, 2024 8:55 am Post subject: |
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kalijah wrote: | I always felt he could have done this more effectively by just selling a .pdf and/or video course on the static exercises and include how to connect your own meter if you wish to track the pressures achieved. |
I’m not sure “effective” is the goal. You can’t charge $75 for a pdf/video. _________________ Andrew Stadler |
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kalijah Heavyweight Member
Joined: 06 Nov 2003 Posts: 3288 Location: Alabama
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Posted: Thu May 23, 2024 9:33 am Post subject: |
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Quote: | I’m not sure “effective” is the goal. You can’t charge $75 for a pdf/video |
Yes, but if the cost is lower the market is greater. And no requirement to produce, handle, ship a physical product. Only a digital one. |
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astadler Veteran Member
Joined: 11 Feb 2014 Posts: 132 Location: Little Rock, AR
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Posted: Thu May 23, 2024 9:34 am Post subject: |
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True, but trumpet players are rather notorious for purchasing gear/gadgets. _________________ Andrew Stadler |
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DanEuph Regular Member
Joined: 17 Aug 2022 Posts: 24 Location: Wales, UK
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Posted: Thu May 23, 2024 10:30 am Post subject: |
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I'm now getting sales pitches via PM on here saying I should buy the product. Unbelievable! |
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LittleRusty Heavyweight Member
Joined: 11 Aug 2004 Posts: 12705 Location: Gardena, Ca
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Posted: Thu May 23, 2024 12:34 pm Post subject: |
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huntman10 wrote: | As a confirmed member of the old fogey generation, and dues paying Medicare subpart whatever health services participant, I am "requested" to show up for annual testing. This last fall, as part of my respiratory exam, I was told to blow into just such a sphygmomanometer gauge. My wife says, "Oh, he has played trumpet for 60 years, he has no problem with that!" To which the technician responded *AHEM*, "I didn't know it could go THAT high!”
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When I was getting allergy shots part of the regimen on shot days was to use a disposable sphygmomanometer to measure the patient’s capacity. I always enjoyed getting a new nurse who hadn’t dealt with me before.
I would explain that those didn’t work for me. The nurse would assure me it was part of the process so I would take a deep breath, exhale and the nurse would hear the loud clicks as I pegged the plastic indicators.
They never asked twice.
Out of curiosity they once took me to the top of the line sphygmomanometer and it indicated I had more than twice the normal capacity. |
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LittleRusty Heavyweight Member
Joined: 11 Aug 2004 Posts: 12705 Location: Gardena, Ca
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Posted: Thu May 23, 2024 12:47 pm Post subject: |
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I am not sure that it matters but the device looks very similar to an automotive compression gauge.
My point being that putting a gauge on the end of a hose is not unique to the medical industry.
I had a classmate and friend in college who lost an eye due to excess pressure while playing the trumpet. The eye was known to have issues before the incident but his experience is always in the back of my mind when using pressure when playing. |
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Rhondo Veteran Member
Joined: 22 Oct 2021 Posts: 339
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Posted: Thu May 23, 2024 1:03 pm Post subject: |
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LittleRusty wrote: | I am not sure that it matters but the device looks very similar to an automotive compression gauge.
My point being that putting a gauge on the end of a hose is not unique to the medical industry.
I had a classmate and friend in college who lost an eye due to excess pressure while playing the trumpet. The eye was known to have issues before the incident but his experience is always in the back of my mind when using pressure when playing. |
I’m going to hope this means lost eyesight and that the eye didn’t pop out and roll across the floor. Yikes |
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