Pflex Em(Tm) (Exercise Monitor)
FDA 510(k) K864719 · Health Products, Inc.
510(k) numberK864719
Submission
- Device name
- Pflex Em(Tm) (Exercise Monitor)
- Applicant
- Health Products, Inc.
Cedar Grove, NJ, US - Received
- December 3, 1986
- Decision date
- March 16, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BWF – Spirometer, Therapeutic (Incentive)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5690
- Specialty
- Anesthesiology
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| K203378 | PulsehalerBWF · Traditional | Respinova, Ltd. | 03/31/2021SE |
| K192000 | D R Burton OxyPAPBWF · Traditional | D R Burton Healthcare, LLC | 02/19/2020SE |
| K181660 | Acapella Choice Blue Vibratory PEP DeviceBWF · Traditional | Smiths Medical | 10/24/2019SE |
| K183108 | Combined Aerobika OPEP and VersaPAP deviceBWF · Traditional | Trudell Medical International | 08/16/2019SE |
| K182847 | Hudson RCI Voldyne Volumetric ExerciserBWF · Traditional | Teleflexmedical, Inc. | 07/01/2019SE |
More from Teleflexmedical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K912866 | Peak Expiratory Flow MeterBZH · Traditional | 08/13/1992SE |
| K912943 | Threshold 2X Inspiratory Muscle TrainerBWF · Traditional | 01/30/1992SE |
| K911807 | Metered Dose Inhaler (Mdi) SpacerCAF · Traditional | 10/23/1991SE |
| K902292 | Modified Assess(R) Peak Flow MeterBZH · Traditional | 08/10/1990SE |
| K896953 | Modified Assess(R) Peak Flow MeterBZH · Traditional | 01/30/1990SE |
| K894353 | Orthoderm ConvertibleIOQ · Traditional | 08/09/1989SE |
| K890426 | Consummate Air Therapy BedFNL · Traditional | 04/05/1989SE |
| K874801 | Orthoderm Therapy BedFNM · Traditional | 02/05/1988SE |
| K871742 | Modified Use of Plex Inspiratory Muscle TrainerBWF · Traditional | 06/15/1987SE |
| K870514 | Threshold(Tm) Inspiratory Muscle TrainerBWF · Traditional | 03/31/1987SE |
Questions and answers
When was Pflex Em(Tm) (Exercise Monitor) cleared by the FDA?
Pflex Em(Tm) (Exercise Monitor) (K864719) received a 510(k) decision of Substantially Equivalent on March 16, 1987, 103 days after the submission was received.
What is the product code of K864719?
The FDA product code is BWF – Spirometer, Therapeutic (Incentive), a Class II (moderate risk) device regulated under 21 CFR 868.5690.