Numiere SM9916
by Hong Qiangxing (Shenzhen) Electronics Limited
Numiere SM9916 is a medical device (FDA Class II; FDA product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes) made by Hong Qiangxing (Shenzhen) Electronics Limited, cleared under FDA 510(k) K171821 on 26 Apr 2018 and listed in FDA GUDID since 18 Nov 2022 (UDI-DI 06971712722976), 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 | Number06971712722976 | Date18 Nov 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171821 | Date26 Apr 2018 | StatusActive |
Official records
- AccessGUDID record 06971712722976
- FDA 510(k) database K171821
Across registries
- FDA 510(k) K171821 decided 26 Apr 2018 Active
- FDA GUDID UDI-DI 06971712722976 listed 18 Nov 2022 Listed
Timeline
- Cleared FDA 510(k) K171821
- Listed FDA GUDID 06971712722976
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Numiere
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / reference
- SM9916
- Primary DI / UDI-DI
- 06971712722976
- FDA product code
- NFO
- GMDN term
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Device class
- Class II
- Regulation number
- 882.5890
- GUDID distribution status
- In Commercial Distribution
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