Aerobika Opep Manometer
Aerobika OPEP Manometer is the pressure-feedback component used with the Aerobika oscillating positive expiratory pressure device. During exhalation, it gives a visible indication of the…
Aerobika OPEP Manometer is the pressure-feedback component used with the Aerobika oscillating positive expiratory pressure device. During exhalation, it gives a visible indication of the pressure generated in the assembly.
A portion of the patient’s exhaled air passes through the manometer, pressurizing its housing and moving the indicator. The mechanism uses the energy of exhaled breath, with no separate power supply.
Connection to OPEP
A polypropylene adapter connects the manometer to the OPEP assembly. The main Aerobika device combines positive expiratory pressure with oscillations during exhalation and can be used alongside nebulized aerosol delivery; the manometer adds visual pressure feedback to that setup.
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 | Trudell Medical International, Canada |
|---|---|
| FDA product code | BWF |
| Device type | Spirometer, Therapeutic (Incentive) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5690 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K150173 |
| Record published | 2020-04-22 |
| Record revised | 2021-06-22 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 25 |
| Distribution end date | 2020-04-22 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 110502 | In distribution | ||
| 110502 | 25 | Withdrawn |
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 |
|---|---|
| K183108 | 2019-08-16 |
| K173918 | 2018-08-17 |
| K150173 | 2015-10-15 |
| K123400 | 2013-05-16 |
| K012368 | 2002-02-12 |
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.