Data / Medical devices / United States / Unika Health Inc.
Unika Health Inc.: FDA-registered device maker in Sunnyvale, CA, United States, 1 510(k) clearance
Unika Health Inc. is registered with the FDA (registration 3047896295) in Sunnyvale, CA, United States. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 3, 2025. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3047896295
- Address
- 880 W Maude Ave, Sunnyvale, CA, United States, 94085
- Owner or operator
- iHealth labs Inc (10078949)
- Roles
- Specification developer
- First device listed
- April 30, 2026
- Registered through
- 2027
- Brand names listed
- Unika Health
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Specification developer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Specification developer | accessdata.fda.gov |
| Oximeter, Infrared, Sporting, Aviation | OCH | 2 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 3, 2025 | K243146 | iCare APP | MWI | Substantially Equivalent | Ihealth Labs, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Analyzer, Body Composition, Exempt
- All makers of Medical Device Data System
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Oximeter, Infrared, Sporting, Aviation
Updated February 3, 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.