Identity
- Trade Name
- Happy Health FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, home-use FDA UDI
- Model / Reference
- Happy Ring HR0901GB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850068747122 FDA UDI
- 510(k) Number
- K240236 FDA UDI
- FDA Product Code
- MWI FDA UDIBZQ FDA UDIDQA FDA UDIDRG FDA UDIFLL FDA UDIGZO FDA UDILEL FDA UDI
- GMDN Term
- Multiple vital physiological parameter monitoring system, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.2300 FDA UDI868.2375 FDA UDI870.2700 FDA UDI870.2910 FDA UDI880.2910 FDA UDI882.1540 FDA UDI882.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Multiple vital physiological parameter monitoring system, home-use
Happy Health by Happy Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Happy Health, Inc.
Sources (1)
- FDA UDI 5b06428e-beba-4854-9088-3d0470addb33 33 fields · synced May 30, 2026