Fem-Gard, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Fem-Gard, Inc. makes
Fem-Gard, Inc. manufactures protective medical devices, including the Heel Gard—a heel protector designed to prevent pressure injuries—and the Cover Gard, a covering intended to reduce friction and shear in patient care settings.
These devices are classified as Class I under FDA regulations and are listed via 510(k) clearance. The company is based in the United States.
Catalogue
Heel Gard Ref K790954
Regimes: 510(k) Registry: 510(k)Cover Gard Ref K790955
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Fem-Gard, Inc. have in the registry?
The registry currently lists 2 devices for Fem-Gard, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Fem-Gard, Inc.'s devices?
Among its 2 most recently registered devices, Fem-Gard, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Fem-Gard, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Fem-Gard, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Fem-Gard, Inc. in the registry?
The most recently registered devices listed for Fem-Gard, Inc. include HEEL GARD and COVER GARD.