AirPhysio
AirPhysio is a handheld positive expiratory pressure device. Its filing describes exhalation through a stainless-steel ball and plastic cone, producing vibrations that assist in loosening…
AirPhysio is a handheld positive expiratory pressure device. Its filing describes exhalation through a stainless-steel ball and plastic cone, producing vibrations that assist in loosening mucus from the airways.
The stated use is to improve mucus clearance while maintaining airway patency during exhalation. The filing also describes use for patients with chronic bronchitis or bronchiectasis when PEP therapy is medically needed.
Listed Item
mucus clearance average lung capacity, OPEP, non invitro, no chemicals, contains one steel ball bearing TEAL coloured box
Operating Principle
The device increases resistance when tilted. Its moving ball opposes exhalation, creating resistance and intermittent endobronchial pressure as the user breathes out.
Who Else Makes It
Registered in Chongqing.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chongqing Sonmol Technology Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 9 |
Record
| Listed by | Airphysio Pty, Ltd., Australia |
|---|---|
| FDA product code | BYI |
| Device type | Percussor, Powered-Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5665 |
| 510(k) | K203209 |
| Record published | 2024-01-22 |
| Record revised | 2025-05-01 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: Please store in a cool dry place outside of direct sunlight. |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| G5® | General Physiotherapy, Inc. | 354 |
| InCourage® | Respiratory Technologies, Inc. | 252 |
| SmartVest | Electromed, Inc. | 172 |
| The Vest®System | Hill-Rom Services Pte, Ltd. | 97 |
| AffloVest | Tactile Systems Technology Inc | 39 |
| ClearChest® | Respiratory Technologies, Inc. | 31 |
| AffloVest | Movair, Inc. | 7 |
| Portex | ICU Medical, Inc | 4 |
| The Vest APX System | Hill-Rom Services Pte, Ltd. | 3 |
| Vibralung® | Westmed, Inc. | 3 |
| Frequencer | Dymedso, Inc. | 3 |
| Vibralung Patient Kit | Westmed, Inc. | 2 |
Showing 12 of 34. All products under Percussor, Powered-Electric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203209 | 2021-01-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.