The Vest®System
Contains 1 XS wrap, 1 S wrap, 2 L wrap, and 1 XL wrap.
1manufacturer
97catalogue numbers in this listing
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 | Hill-Rom Services Pte, Ltd., Singapore |
|---|---|
| FDA product code | BYI |
| Device type | Percussor, Powered-Electric |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5665 |
| 510(k) | K024309 |
| Record published | 2016-09-17 |
| Record revised | 2022-08-29 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| Packaging | Pack of 5, pack of 2, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| P300634000 | In distribution | |
| 500350004 | In distribution | |
| P300645000 | In distribution | |
| 500370004 | In distribution | |
| P300282001 | In distribution | |
| 500300002 | In distribution | |
| 500320004 | In distribution | |
| 500450000 | In distribution | |
| 500340005 | In distribution | |
| 500400000 | In distribution | |
| 500360001 | In distribution | |
| 500360002 | In distribution | |
| 500430000 | In distribution | |
| 200426000 | In distribution | |
| P300215000 | In distribution | |
| P300284000 | In distribution | |
| 500460000 | In distribution | |
| P205 | In distribution | |
| P300232000 | In distribution | |
| 500310002 | In distribution | |
| P300629000 | In distribution | |
| 500330004 | In distribution | |
| P300630000 | In distribution | |
| P300281001 | In distribution | |
| P300200000 | In distribution | |
| 205000 | In distribution | |
| 500340001 | In distribution | |
| P300210000 | In distribution | |
| P300284001 | In distribution | |
| 500320006 | In distribution | |
| P105cm | In distribution | |
| 500310003 | In distribution | |
| P300641000 | In distribution | |
| P300644000 | In distribution | |
| P300292001-01 | In distribution | |
| 200495000 | In distribution | |
| P205cm | In distribution | |
| P300642000 | In distribution | |
| P300633000 | In distribution | |
| P300231000 | In distribution | |
| 500320005 | In distribution | |
| 105000 | In distribution | |
| 500350001 | In distribution | |
| P300285000 | In distribution | |
| 500370006 | In distribution | |
| 500310006 | In distribution | |
| 500310005 | In distribution | |
| 500330001 | In distribution | |
| 500360004 | In distribution | |
| 500330002 | In distribution | |
| 500350002 | In distribution | |
| P300230000 | In distribution | |
| 500370003 | In distribution | |
| P300631000 | In distribution | |
| 500330006 | In distribution | |
| P300208000 | In distribution | |
| P004982 | In distribution | |
| 500420000 | In distribution | |
| 500360003 | In distribution | |
| 500350005 | In distribution | |
| 500310001 | In distribution | |
| 500340002 | In distribution | |
| 500370002 | In distribution | |
| P300220000 | In distribution | |
| 500320002 | In distribution | |
| P300643000 | In distribution | |
| 500330003 | In distribution | |
| 500360005 | In distribution | |
| 500340004 | In distribution | |
| 500300003 | In distribution | |
| 500350003 | In distribution | |
| P105BT | In distribution | |
| 500470000 | In distribution | |
| P300632000 | In distribution | |
| P105 | In distribution | |
| P300290001 | In distribution | |
| P300286001-001 | In distribution | |
| 500340006 | In distribution | |
| P300233000 | In distribution | |
| 500370005 | In distribution | |
| 500410000 | In distribution | |
| 500330005 | In distribution | |
| P300205000 | In distribution | |
| P300288001 | In distribution | |
| P300640000 | In distribution | |
| 500320003 | In distribution | |
| 500360006 | In distribution | |
| 500340003 | In distribution | |
| P300286001 | In distribution | |
| P300600005 | In distribution | |
| 500320001 | In distribution | |
| 500440000 | In distribution | |
| 500370001 | In distribution | |
| 500350006 | In distribution | |
| 500310004 | In distribution | |
| P300292001 | In distribution | |
| P300280001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| G5® | General Physiotherapy, Inc. | 354 |
| InCourage® | Respiratory Technologies, Inc. | 252 |
| SmartVest | Electromed, Inc. | 172 |
| 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 |
| Monarch™ System | Hill-Rom Services Pte, Ltd. | 2 |
Showing 12 of 34. All products under Percussor, Powered-Electric
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K163378 | 2017-03-17 |
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.