Healthetech, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Healthetech, Inc. makes
Healthetech, Inc. manufactures the MEDGEM, a medical device designed for patient monitoring and diagnostic support, and the BODYGEM (Model HB211), a wearable sensor system for continuous physiological data collection.
The company’s portfolio consists of Class II devices, authorised via the FDA’s 510(k) pathway. These products are listed under U.S. regulatory requirements and are based in the United States.
Catalogue
Medgem Ref K021605
Regimes: 510(k) Registry: 510(k)Bodygem, Model HB211 Ref K010577
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Healthetech, Inc. have in the registry?
The registry currently lists 2 devices for Healthetech, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healthetech, Inc.'s devices?
Among its 2 most recently registered devices, Healthetech, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Healthetech, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Healthetech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Healthetech, Inc. in the registry?
The most recently registered devices listed for Healthetech, Inc. include MEDGEM and BODYGEM, MODEL HB211.