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peanuts56
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Joined: 21 Nov 2021
Posts: 246
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 Posted: Thu May 23, 2024 1:16 pm Post subject: |
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Legal issues aside, I had lunch recently with a trumpet playing friend. He's a very fine player, usually plays lead in several different situations.
He has one of Larry's devices and raved about it. |
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Uberopa
Heavyweight Member
Joined: 11 Dec 2003
Posts: 939
Location: Canada
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| Posted: Thu May 23, 2024 1:28 pm Post subject: |
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| My question regards the actual function of the system. How does the system use differ from the Valsalva Maneuver which is breathing out against a closed throat? Does the device provide enough air passage to be prevent a dangerous rise in blood pressure? Have I answered my own question? |
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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 3:43 pm Post subject: |
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| Rhondo wrote: | | 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 |
The eye sight was lost and the eye was surgically removed and replaced by a glass eye.
After my previous post I googled the fellow and he is actively playing as a pro. |
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stuartissimo
Heavyweight Member
Joined: 17 Dec 2021
Posts: 1049
Location: Europe
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| Posted: Thu May 23, 2024 11:38 pm Post subject: |
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To the OP: if you feel that strongly about it, have you considered reporting it to the FDA themselves? They’re best able to determine whether something violates FDA rules.
_________________
1975 Olds Recording trumpet
1997 Getzen 700SP trumpet
1955 Olds Super cornet
1939 Buescher 280 flugelhorn
AR Resonance mpc |
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DanEuph
Regular Member
Joined: 17 Aug 2022
Posts: 24
Location: Wales, UK
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| Posted: Fri May 24, 2024 2:18 pm Post subject: |
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| stuartissimo wrote: | | To the OP: if you feel that strongly about it, have you considered reporting it to the FDA themselves? They’re best able to determine whether something violates FDA rules. |
We'll see what happens... If the seller comes forward and says that they'll get the device properly assessed then we'll be golden. As it stands, they are unwilling to answer questions and only seem interested in trying to get me to buy the product or bombarding me with artist testimonials, as if the latter actually means anything... |
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Chadwick
Veteran Member
Joined: 04 Oct 2009
Posts: 150
Location: United States
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| Posted: Fri May 24, 2024 2:46 pm Post subject: |
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| DanEuph wrote: | | stuartissimo wrote: | | To the OP: if you feel that strongly about it, have you considered reporting it to the FDA themselves? They’re best able to determine whether something violates FDA rules. |
We'll see what happens... If the seller comes forward and says that they'll get the device properly assessed then we'll be golden. As it stands, they are unwilling to answer questions and only seem interested in trying to get me to buy the product or bombarding me with artist testimonials, as if the latter actually means anything... |
If you have a legitimate legal concern about this product, you really should consider contacting FDA's Office of Regulatory Affairs. These folks won't fault you for asking a good-faith question, and you can use them as a sounding board for your concerns.
IMO this forum is not a good place to get specific legal advice about your questions. In any event, best of success with your inquiry! |
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SatchmoGillespie
Heavyweight Member
Joined: 16 Jul 2004
Posts: 1809
Location: Dallas, Texas
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| Posted: Sat May 25, 2024 10:01 am Post subject: |
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| DanEuph wrote: | | stuartissimo wrote: | | To the OP: if you feel that strongly about it, have you considered reporting it to the FDA themselves? They’re best able to determine whether something violates FDA rules. |
We'll see what happens... If the seller comes forward and says that they'll get the device properly assessed then we'll be golden. As it stands, they are unwilling to answer questions and only seem interested in trying to get me to buy the product or bombarding me with artist testimonials, as if the latter actually means anything... |
Seems like you're hellbent on trying to discredit the device.
_________________
Jim New S5 M and MS with C Backbore
Del Quadro Grizzly
Stomvi USA Bb
Getzen Severinsen
Kanstul 1525 Flugelhorn |
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DanEuph
Regular Member
Joined: 17 Aug 2022
Posts: 24
Location: Wales, UK
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| Posted: Sat May 25, 2024 1:55 pm Post subject: |
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| SatchmoGillespie wrote: | | DanEuph wrote: | | stuartissimo wrote: | | To the OP: if you feel that strongly about it, have you considered reporting it to the FDA themselves? They’re best able to determine whether something violates FDA rules. |
We'll see what happens... If the seller comes forward and says that they'll get the device properly assessed then we'll be golden. As it stands, they are unwilling to answer questions and only seem interested in trying to get me to buy the product or bombarding me with artist testimonials, as if the latter actually means anything... |
Seems like you're hellbent on trying to discredit the device. |
I'm hellbent on discrediting those who conduct illegal business practices and potentially jeopardise the safety of their clients... I'm such a radical! |
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LittleRusty
Heavyweight Member
Joined: 11 Aug 2004
Posts: 12705
Location: Gardena, Ca
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| Posted: Sat May 25, 2024 2:26 pm Post subject: |
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| DanEuph wrote: | | I'm hellbent on discrediting those who conduct illegal business practices and potentially jeopardise the safety of their clients... I'm such a radical! |
Without meaning to offend nor to escalate I wonder why you have chosen this windmill to tilt at.
Assuming you are correct that a non tested nor FDA approved use of this device is potentially harmful I fail to see an issue that warrants your passion and concern. |
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Trumpjerele
Veteran Member
Joined: 20 Feb 2019
Posts: 190
Location: Spain
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| Posted: Sat May 25, 2024 2:33 pm Post subject: |
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There are many respiratory-related medical devices used by wind musicians.
Arnold Jacob popularized their use, I don't know if anyone before him did as well.
For example I used a device called "inspiron" designed to measure inspiratory capacity.
You would turn it upside down and put the mouthpiece in place of the tube and vibrate it trying to keep a little ball on top. It also had a little wheel to regulate the resistance.
At the beginning they were sold in pharmacies, nowadays music stores also have these breathing accessories.
_________________
Notice!!! Amateur musician without formal studies
Trumpet: Yamaha 8310Z
Mouthpiece: the great Yamaha11b4
Sax tenor: Yamaha YTS 23
Mouthpiece: Otto link tone edge |
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SatchmoGillespie
Heavyweight Member
Joined: 16 Jul 2004
Posts: 1809
Location: Dallas, Texas
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| Posted: Sat May 25, 2024 3:29 pm Post subject: |
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| DanEuph wrote: | | SatchmoGillespie wrote: | | DanEuph wrote: | | stuartissimo wrote: | | To the OP: if you feel that strongly about it, have you considered reporting it to the FDA themselves? They’re best able to determine whether something violates FDA rules. |
We'll see what happens... If the seller comes forward and says that they'll get the device properly assessed then we'll be golden. As it stands, they are unwilling to answer questions and only seem interested in trying to get me to buy the product or bombarding me with artist testimonials, as if the latter actually means anything... |
Seems like you're hellbent on trying to discredit the device. |
I'm hellbent on discrediting those who conduct illegal business practices and potentially jeopardise the safety of their clients... I'm such a radical! |
You’re not a radical. You’re just someone with a bullsh*t axe to grind.
_________________
Jim New S5 M and MS with C Backbore
Del Quadro Grizzly
Stomvi USA Bb
Getzen Severinsen
Kanstul 1525 Flugelhorn |
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