Aerobika Opep With Manometer
Aerobika OPEP with Manometer combines positive expiratory pressure with oscillations during exhalation. It is mechanically driven by the patient’s breath and is intended for patients able…
Aerobika OPEP with Manometer combines positive expiratory pressure with oscillations during exhalation. It is mechanically driven by the patient’s breath and is intended for patients able to generate an exhalation flow of 10 litres per minute for three to four seconds.
Part of the exhaled air passes through the manometer, moving an indicator that shows expiratory pressure. The exhalation resistance can be adjusted, and the device works independently of orientation. A removable mouthpiece can stay in the mouth throughout treatment.
Listed Item
AEROBIKA OPEP with Manometer (package of 10)
Combined Use and Cleaning
The device may be used at the same time as nebulized aerosol drug delivery. It can be disassembled for cleaning, but the manometer indicator is not intended to be cleaned. The assembly is supplied nonsterile for prescription use with a single patient.
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 | 2016-09-24 |
| 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 10 |
| Distribution end date | 2020-04-22 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 110504 | In distribution | ||
| 110504 | 10 | Withdrawn |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.