LibAirty Airway Clearance System
Catalogue number L10008V2, listed by Synchrony Medical Ltd, Israel, under Percussor, Powered-Electric. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1510(k) clearance
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 | Synchrony Medical Ltd, Israel |
|---|---|
| FDA product code | BYI |
| Device type | Percussor, Powered-Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5665 |
| Establishment | Manufacturer |
| 510(k) | K242063 |
| Record published | 2025-05-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| L10008V2 | 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 |
|---|---|
| K242063 | 2024-12-19 |
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.