Data / Medical devices / United States / Happy Health
Happy Health: FDA-registered device maker in Austin, TX, United States, 2 510(k) clearances
Happy Health is registered with the FDA (registration 3033715634) in Austin, TX, United States. It lists 9 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 18, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3033715634
- Address
- 3200 Gracie Kiltz Ln Ste 301, Austin, TX, United States, 78758
- Owner or operator
- Happy Health (10091422)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- October 3, 2024
- Registered through
- 2026
- Brand names listed
- Happy Health Home Sleep Test, Happy Ring Health Monitoring System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Galvanic Skin Response Measurement | GZO | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Device, Sleep Assessment | LEL | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Monitor, Breathing Frequency | BZQ | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Oximeter | DQA | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Reduced- Montage Standard Electroencephalograph | OMC | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | 2 | Complaint file establishment, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Ventilatory Effort Recorder | MNR | 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 |
|---|---|---|---|---|---|---|
| June 18, 2025 | K242224 | Happy Health Home Sleep Test | MNR | Substantially Equivalent | Happy Health, Inc. | accessdata.fda.gov |
| September 24, 2024 | K240236 | Happy Ring Health Monitoring System | MWI | Substantially Equivalent | Happy Health, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Reduced- Montage Standard Electroencephalograph
- All makers of Ventilatory Effort Recorder
- All makers of Oximeter
- All makers of Device, Galvanic Skin Response Measurement
- All makers of Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
- All makers of Monitor, Breathing Frequency
Updated June 18, 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.