AffloVest
The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motors organized into zones. The vest may be run on battery or A/C power from a standard wall…
The AffloVest is comprised of a vest of synthetic polymer fabric with oscillating vibratory motors organized into zones. The vest may be run on battery or A/C power from a standard wall outlet. The AffloVest is intended for promoting airway clearance and improvement of bronchial drainage by enhancing mobilization of bronchial secretions where external manipulation of the thorax is the physician’s choice of treatment.
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 | Movair, Inc. |
|---|---|
| FDA product code | BYI |
| Device type | Percussor, Powered-Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5665 |
| 510(k) | K122480 |
| Record published | 2015-11-24 |
| Record revised | 2025-02-24 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Distribution end date | 2022-04-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8100XXS | Withdrawn | |
| 8300XL | Withdrawn | |
| 8100XS | Withdrawn | |
| 8300 | Withdrawn | |
| 8100 | Withdrawn | |
| 8300XXL | Withdrawn | |
| 8200 | Withdrawn |
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 |
| 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 |
| Monarch™ System | Hill-Rom Services Pte, Ltd. | 2 |
Showing 12 of 34. All products under Percussor, Powered-Electric
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.