Faceheart Corp.
Cayman IslandsFDA 510(k) applicant, unverified FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Faceheart Corp. makes
Faceheart Corp. develops software development kits for remote physiological monitoring, including the FaceHeart Vitals SDK and its research version (FH vitals SDK-RR), which enable non-invasive tracking of vital signs via facial imaging technology.
These products are classified as Class II medical devices under FDA regulations and are listed via 510(k) premarket notifications. The company operates from the United States.
Catalogue
- 510(k) 510(k)
- 510(k) 510(k)
FDA establishments
- Faceheart Corp. Taiwan Hsinchu(City) · TW FEI 3028169073
Frequently asked questions
How many devices does Faceheart Corp. have in the registry?
The registry currently lists 2 devices for Faceheart Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Faceheart Corp.'s devices?
Among its 2 most recently registered devices, Faceheart Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Faceheart Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Faceheart Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Faceheart Corp. in the registry?
The most recently registered devices listed for Faceheart Corp. include FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) and FaceHeart Vitals Software Development Kit (FH vitals SDK).
Which FDA establishments are linked to Faceheart Corp.?
1 FDA establishment is linked to Faceheart Corp. in the registry; they are listed on the company page.