Data / Medical devices / United States / Big Health Inc
Big Health Inc: FDA-registered device maker in Newport Beach, CA, United States, 2 510(k) clearances
Big Health Inc is registered with the FDA (registration 3024442350) in Newport Beach, CA, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 30, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3024442350
- Address
- 2067 Port Bristol Cir, Newport Beach, CA, United States, 92660
- Owner or operator
- Big Health (10088537)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 2, 2025
- Registered through
- 2026
- Brand names listed
- DaylightRx Treatment, SleepioRx
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Computerized Behavioral Therapy Device For Anxiety Disorders | SCP | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Computerized Behavioral Therapy Device For Insomnia | QVO | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| August 30, 2024 | K233872 | Daylight | SCP | Substantially Equivalent | Big Health, Inc. | accessdata.fda.gov |
| August 5, 2024 | K233577 | Sleepio® | QVO | Substantially Equivalent | Big Health, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 30, 2024. 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.