# Happy Health, Inc.

- Location (FDA's records): Austin, TX
- FDA decisions: 3 (2024–2026): 3 510(k) clearances
- Product codes: MNR (1), MWI (1), DXN (1)
- 510(k) review time since 2016: median 262 days, against 165 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ectosense NV: 1 (https://510kreport.com/company/ectosense)
- Empatica S.r.l.: 1 (https://510kreport.com/company/empatica)
- Aktiia SA: 1 (https://510kreport.com/company/aktiia)

## Recent decisions
- K254000: Happy Health Blood Pressure Monitor (Sep 3, 2026)
- K242224: Happy Health Home Sleep Test (Jun 18, 2025)
- K240236: Happy Ring Health Monitoring System (Sep 24, 2024)

Source page: https://510kreport.com/company/happy-health