510(k) K261131 ยท NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)
| Applicant | Shenzhen Osto Medical Technology Co.,Ltd, Shenzhen, CN |
| Decision | Substantially Equivalent, Sep 6, 2026 |
| Received | Apr 6, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261131
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.