The Legality and Safety of the Compression Training System

[DanEuph]

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,

[cbtj51]

on 2nd thought...


Life is Short, find the Joy in it!

Mike
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[JayKosta]

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.
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Most Important Note ? - the next one !
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[DanEuph]

[JayKosta]

[DanEuph]

[DanEuph]

[huntman10]

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.
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huntman10
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[kalijah]

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.

[DanEuph]

[Rhondo]

Why would the seller block you if all you were doing was asking a question?

[DanEuph]

[kalijah]

[astadler]

[kalijah]

[astadler]

True, but trumpet players are rather notorious for purchasing gear/gadgets.
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Andrew Stadler

[DanEuph]

I'm now getting sales pitches via PM on here saying I should buy the product. Unbelievable!

[LittleRusty]

[LittleRusty]

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.

[Rhondo]