Apolomed HS-591
by Shanghai Apolo Medical Technology Co., Ltd
Apolomed HS-591 is a deep-tissue electromagnetic stimulation system (FDA Class II; FDA product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning) made by Shanghai Apolo Medical Technology Co., Ltd, cleared under FDA 510(k) K232409 on 10 Apr 2024 and listed in FDA GUDID since 30 Apr 2024 (UDI-DI 06970745915911), 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 | Number06970745915911 | Date30 Apr 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK232409 | Date10 Apr 2024 | StatusActive |
Official records
- AccessGUDID record 06970745915911
- FDA 510(k) database K232409
Across registries
- FDA 510(k) K232409 decided 10 Apr 2024 Active
- FDA GUDID UDI-DI 06970745915911 listed 30 Apr 2024 Listed
Timeline
- Cleared FDA 510(k) K232409
- Listed FDA GUDID 06970745915911
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Apolomed
- Generic name
- Deep-tissue electromagnetic stimulation system, professional
- Model / reference
- HS-591
- Primary DI / UDI-DI
- 06970745915911
- 510(k) Number
- FDA product code
- NGX
- GMDN term
- Deep-tissue electromagnetic stimulation system, professional
- Device class
- Class II
- Regulation number
- 890.5850
- GUDID distribution status
- In Commercial Distribution
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