Goyibam AST-300F
by Shenzhen Osto Technology Co., Ltd.
Goyibam AST-300F is a Class II device made by Shenzhen Osto Technology Co., Ltd., cleared under FDA 510(k) K190673 on 12 Dec 2019 and listed in FDA GUDID since 20 Jun 2020 (UDI-DI 06950940801363), 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 | Number06950940801363 | Date20 Jun 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190673 | Date12 Dec 2019 | StatusActive |
Official records
- AccessGUDID record 06950940801363
- FDA 510(k) database K190673
Across registries
- FDA 510(k) K190673 decided 12 Dec 2019 Active
- FDA GUDID UDI-DI 06950940801363 listed 20 Jun 2020 Listed
Timeline
- Cleared FDA 510(k) K190673
- Listed FDA GUDID 06950940801363
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Goyibam
- Generic name
- Acupuncture electrical stimulation system
- Model / reference
- AST-300F
- Primary DI / UDI-DI
- 06950940801363
- 510(k) Number
- FDA product code
- NGX, NUH
- GMDN term
- Acupuncture electrical stimulation system
- Device class
- Class II
- Regulation number
- 890.5850, 882.5890
- GUDID distribution status
- In Commercial Distribution
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