Data / Medical devices / Taiwan / Faceheart Corp.
Faceheart Corp.: FDA-registered device maker in Taiwan Hsinchu(City), Taiwan, 2 510(k) clearances
Faceheart Corp. is registered with the FDA (registration 3028169073) in Taiwan Hsinchu(City), Taiwan. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 9, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3028169073
- Address
- Rm.1003, 10F., Jan Qi Biomedical Engineering Building, No.75, Bo'ai St., East Dist., Taiwan Hsinchu(City), Taiwan, 300
- Owner or operator
- FaceHeart Corporation (10088632)
- Roles
- Manufacturer
- First device listed
- September 10, 2023
- Registered through
- 2026
- Brand names listed
- Software, non contact, optical camera-based measurement of pulse rate, Software, non contact, optical camera-based measurement of respiratory rate
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Monitor, Breathing Frequency | BZQ | 2 | Manufacturer | accessdata.fda.gov |
| Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate | QME | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 9, 2025 | K243966 | FaceHeart Vitals Software Development Kit (FH vitals SDK-RR) | BZQ | Substantially Equivalent | Faceheart Corp. | accessdata.fda.gov |
| September 1, 2023 | K223622 | FaceHeart Vitals Software Development Kit (FH vitals SDK) | QME | Substantially Equivalent | Faceheart Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
- All makers of Monitor, Breathing Frequency
Updated April 9, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.