FDA Registration
Active
🇺🇸 United States
Happy Ring Health Monitoring System
Reg #: 3033715634
·
FEI: 3033715634
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- HAPPY HEALTH
- Registration Number
- 3033715634
- FEI Number
- 3033715634
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 3200 Gracie Kiltz Ln Ste 301
- City
- Austin
- State
- TX
- ZIP
- 78758
- Country
- US
Regulatory Submissions
- 510(k) Number
- K240236
Owner / Operator
- Firm Name
- Happy Health
- Operator Number
- 10091422
- Address
- 3200 Gracie Kiltz Ln., Ste. 301
- City
- Austin
- State
- TX
- Postal Code
- 78758
- Country
- US
- Correspondent
- David Carr
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2024-10-03 |
| Device, Galvanic Skin Response Measurement | GZO | Class 2 | Neurology | No | 2024-10-03 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2024-10-03 |
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2024-10-03 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2024-10-03 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2024-10-03 |
| Device, Sleep Assessment | LEL | Class 2 | Neurology | No | 2024-10-03 |
Proprietary Names
Happy Ring Health Monitoring System
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device