The following data is part of a premarket notification filed by Shenzhen Osto Technology Company Limited with the FDA for Electronic Muscle Stimulator (model: Ast-300a, Ast-300n, Ast-300s, Ast-300t, Ast-300v, Ast-300w).
| Device ID | K211736 |
| 510k Number | K211736 |
| Device Name: | Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Shenzhen OSTO Technology Company Limited No.43 Longfeng Road, Xinsheng Community, Longgang Street Longgang District Shenzhen, CN 518116 |
| Contact | Li Yang |
| Correspondent | Cassis Lee Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, CN 510700 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-07 |
| Decision Date | 2021-09-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06950940801769 | K211736 | 000 |
| 06950940801981 | K211736 | 000 |