Healthpal FE-0161
by Xiamen Healthpal Electronic Co., Ltd
Healthpal FE-0161 is a Class II device made by Xiamen Healthpal Electronic Co., Ltd, cleared under FDA 510(k) K211850 on 3 Mar 2022 and listed in FDA GUDID since 4 Jan 2025 (UDI-DI 06974000130002), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number06974000130002 | Date4 Jan 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK211850 | Date3 Mar 2022 | StatusActive |
Official records
- AccessGUDID record 06974000130002
- FDA 510(k) database K211850
Across registries
- FDA 510(k) K211850 decided 3 Mar 2022 Active
- FDA GUDID UDI-DI 06974000130002 listed 4 Jan 2025 Listed
Timeline
- Cleared FDA 510(k) K211850
- Listed FDA GUDID 06974000130002
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Healthpal
- Generic name
- Hand-held deep-tissue electromagnetic stimulator
- Model / reference
- FE-0161
- Primary DI / UDI-DI
- 06974000130002
- 510(k) Number
- FDA product code
- IRP
- GMDN term
- Hand-held deep-tissue electromagnetic stimulator
- Device class
- Class II
- Regulation number
- 890.5650
- GUDID distribution status
- In Commercial Distribution
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