Care Electronics, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Care Electronics, Inc. makes
Care Electronics, Inc. manufactures the Wander Care, a device for monitoring and managing patient mobility and fall risk, and the Dermillume RED (Model HR1000) and Dermillume (Model PRO1000), which appear to be handheld diagnostic tools for skin analysis or lesion imaging.
The company’s portfolio includes Class I and Class II devices, all of which are listed under the FDA’s 510(k) pathway. These products are regulated under US medical device laws and are based in the United States.
Catalogue
Wander Care Ref K925529
Regimes: 510(k) Registry: 510(k)Dermillume Red, Model HR1000 Ref K051681
Regimes: 510(k) Registry: 510(k)Dermillume, Model PRO1000 Ref K043575
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Care Electronics, Inc. have in the registry?
The registry currently lists 3 devices for Care Electronics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Care Electronics, Inc.'s devices?
Among its 3 most recently registered devices, Care Electronics, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Care Electronics, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Care Electronics, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Care Electronics, Inc. in the registry?
The most recently registered devices listed for Care Electronics, Inc. include WANDER CARE, DERMILLUME RED, MODEL HR1000 and DERMILLUME, MODEL PRO1000.