Healthmate, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Healthmate, Inc. makes
Healthmate, Inc. manufactures surgical support equipment, including operating room stands and adjustable support arms designed for intraoperative use. The company also produces the Fluroscan/TM, a device for imaging-related applications in surgical settings.
The portfolio includes Class I and Class II devices, with some products authorised via the FDA’s 510(k) pathway. These devices are listed under US regulatory requirements, and the company is based in the United States.
Catalogue
Operating Room Stand Ref K840027
Regimes: 510(k) Registry: 510(k)Support Arm Ref K854162
Regimes: 510(k) Registry: 510(k)Fluoroscan/Tm By Healthmate Ref K843920
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Healthmate, Inc. have in the registry?
The registry currently lists 3 devices for Healthmate, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healthmate, Inc.'s devices?
Among its 3 most recently registered devices, Healthmate, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Healthmate, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Healthmate, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Healthmate, Inc. in the registry?
The most recently registered devices listed for Healthmate, Inc. include OPERATING ROOM STAND, SUPPORT ARM and FLUOROSCAN/TM BY HEALTHMATE.