Electrical Muscle Stimulator (AST-105DJ)
by Shenzhen OSTO Medical Technology Company Limited China 510(k)
510(k) K261131 Product code NUH
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK261131 | Date6 Sep 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NUH
- FDA applicant
- Shenzhen Osto Medical Technology Co.,Ltd
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
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Properties & raw data
Show properties, registry sources and raw records
Sources (1)
- FDA 510(k) K261131-1