Incentive SPIROMETER,600/900/1200ML
The Besmed TriBall incentive spirometer is a breathing exerciser for patients who need inspiratory exercise. It is intended for hospital or home care use, giving visual feedback as the…
The Besmed TriBall incentive spirometer is a breathing exerciser for patients who need inspiratory exercise. It is intended for hospital or home care use, giving visual feedback as the patient inhales through a mouthpiece and flexible tube.
Inhalation draws air through the unit and causes three balls to rise in their chambers. The balls indicate inspiratory flow rates of 600, 900 and 1,200 cubic centimeters per second. Their movement gives the patient a visible target during repeated deep-breathing exercises.
Supply and Reuse
The spirometer is supplied nonsterile as a disposable device. It is intended for multiple uses by one patient rather than use across different patients.
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 | Besmed Health Business Corporation, Taiwan |
|---|---|
| FDA product code | BWF |
| Device type | Spirometer, Therapeutic (Incentive) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5690 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K133873 |
| Record published | 2016-09-06 |
| Record revised | 2023-11-17 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TB-93100 | 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 |
|---|---|
| K141355 | 2014-09-03 |
| K133873 | 2014-04-04 |
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.