Sanitas, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Sanitas, Inc. makes
Sanitas, Inc. manufactures the WELLaho Personalized Outpatient Management System, a software-as-a-medical-device solution designed for remote patient monitoring and care coordination. They also produce Family Healthware, a digital health platform focused on tracking and managing family health metrics and wellness data in a centralized system.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. These products are intended for use within the United States, where they are subject to compliance with the FDA’s medical device regulations.
Catalogue
- Registry: GUDID
- Registry: GUDID
- Regimes: 510(k) Registry: 510(k)
Family Healthware Ref K132173
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 968618426
- [email protected]
- Phone
- (877) 504-6575
Frequently asked questions
How many devices does Sanitas, Inc. have in the registry?
The registry currently lists 4 devices for Sanitas, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sanitas, Inc.'s devices?
Among its 4 most recently registered devices, Sanitas, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sanitas, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Sanitas, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sanitas, Inc. in the registry?
The most recently registered devices listed for Sanitas, Inc. include Family Healthware™ Version 2.0 Released 20160615, Sanitas™ Clinical Care Platform Version 3.0 Released 20160615, WELLAHO PERSONALIZED OUTPATIENT MANAGEMENT SYSTEM and FAMILY HEALTHWARE.