The Vest APX System
Home Care packaging for The Vest APX, WAR
1manufacturer
2catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Vincent Medical (Dong Guan) Manufacturing Co., Ltd. | Dong Guan | Guangdong | Contract manufacturer | 29 |
Record
| Listed by | Hill-Rom Services Pte, Ltd., Singapore |
|---|---|
| FDA product code | NHJ |
| Device type | Device, Positive Pressure Breathing, Intermittent |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5905 |
| Record published | 2026-03-18 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -25 to 70 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M08368A | In distribution | |
| M08368W | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| CoughAssist | Respironics Inc. | 44 |
| Percussionaire | Percussionaire Corp. | 40 |
| The MetaNeb®System | Hill-Rom Services Pte, Ltd. | 14 |
| The VitalCough®System | Hill-Rom Services Pte, Ltd. | 10 |
| Synclara Cough System | Hill-Rom Services Pte, Ltd. | 10 |
| Volara System | Hill-Rom Services Pte, Ltd. | 9 |
| Vocsn Patient Breathing Package | Ventec Life Systems, Inc. | 7 |
| Clearo | Breas Medical, Inc. | 6 |
| Maximus System | Hill-Rom Services Pte, Ltd. | 6 |
| BiWaze Clear Dual Lumen Circuit With Face Mask – Adult Small | Abmrc LLC | 3 |
| BiWaze Cough Dual Lumen Circuit With Face Mask – Adult Large | Abmrc LLC | 3 |
| Vortran PercussiveNEB 2.0 w/ Top Nebulizer Port | Vortran Medical Technology 1, Inc. | 1 |
Showing 12 of 32. All products under Device, Positive Pressure Breathing, Intermittent
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K200988 | 2020-05-26 |
| K192143 | 2020-02-14 |
| K151689 | 2016-03-17 |
| K124032 | 2013-04-25 |
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.