vPEP Opep Device
The vPEP is a handheld oscillating positive expiratory pressure device used for breathing therapy. The patient exhales through its mouthpiece to create vibrating pressure. It is intended…
The vPEP is a handheld oscillating positive expiratory pressure device used for breathing therapy. The patient exhales through its mouthpiece to create vibrating pressure. It is intended for patients able to sustain an exhalation flow of 10 liters per minute for three to four seconds.
A flap valve generates oscillations as air is breathed out, and a variable exhalation opening allows pressure adjustment. The device is supplied as a preassembled standalone PEP unit, using the same internal PEP components as the iPEP system’s removable cartridge.
Use and Cleaning
vPEP is intended for single-patient reuse in hospital, clinical and home care settings. Its cleaning method uses rinsing with soap and water.
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Ainengke Electronics Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Chinamed Products (China) Ltd. | Gaoyao District | Guangdong | Manufacturer | 8 |
| Shenzhen Gwode Technology Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 2 |
Record
| Listed by | D R Burton Healthcare, LLC, United States |
|---|---|
| FDA product code | BWF |
| Device type | Spirometer, Therapeutic (Incentive) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5690 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K160636 |
| Record published | 2017-01-27 |
| Record revised | 2026-05-21 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 10, case of 2, box of 12, box of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Portex | ICU Medical, Inc | 42 |
| Hudson RCI | Teleflex Medical LLC | 26 |
| AirLife™ | Airlife, Inc. | 11 |
| AIM | Vitalograph Ireland Ltd. | 9 |
| AirLife | Carefusion | 8 |
| Prochamber Assembly | Respironics Respiratory Drug Delivery (Uk), Ltd. | 6 |
| Threshold | Respironics Respiratory Drug Delivery (Uk), Ltd. | 6 |
| Curaplex | Bound Tree Medical, LLC | 5 |
| Hudson RCI | Medline Industries, Inc. | 5 |
| VersaPAP™ Positive Airway Pressure Device | Trudell Medical International | 4 |
| Curaplex | TRI-Anim Health Services, Inc. | 4 |
| Halyard | Owens & Minor Distribution, Inc. | 4 |
Showing 12 of 67. All products under Spirometer, Therapeutic (Incentive)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K192000 | 2020-02-19 |
| K160636 | 2016-08-03 |
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.