Identity
- Trade Name
- Happy Health FDA UDI
- Generic Name
- Multiple vital physiological parameter monitoring system, home-use FDA UDI
- Model / Reference
- Happy Ring HR1301GB FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850068747160 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
Similar devices
Also classified as Multiple vital physiological parameter monitoring system, home-use.
- BabySat 3 Rx Base Station — Owlet Baby Care, Inc. · Class II
- Complete Blood Pressure Monitor +EKG — Omron Healthcare, Inc. · Class II
- Dream Sock Monitoring System - Mint (Duo) — Owlet Baby Care, Inc. · Class II
- Empatica Health Monitoring Platform — EMPATICA SRL · Class II
- Dream Sock Monitoring System - Bedtime Blue — Owlet Baby Care, Inc. · Class II
- Dream Sock Monitoring System - Mint — Owlet Baby Care, Inc. · Class II
- Dream Sock Monitoring System - Wild Child — Owlet Baby Care, Inc. · Class II
- Dream Sock Monitoring System - Bedtime Blue (Duo) — Owlet Baby Care, Inc. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Happy Health, Inc.
Sources (1)
- FDA UDI 7c05dd3a-2967-45a5-866b-39e7b6448618 34 fields · synced May 30, 2026