The following data is part of a premarket notification filed by Shenzhen Osto Technology Company Limited with the FDA for Health Expert Electronic Stimulator (model: Ast-3000l).
| Device ID | K190783 |
| 510k Number | K190783 |
| Device Name: | Health Expert Electronic Stimulator (model: AST-3000L) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Shenzhen OSTO Technology Company Limited No.43 Longfeng Road, Xinsheng Community, Longgang Street Longgang District,shenzhen City, CN 518116 |
| Contact | Li Yang |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Room 2231, Building 1, Ruifeng Center, Kaichuang Road Huangpu District Guangzhou, CN 51006 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-27 |
| Decision Date | 2020-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06950940801332 | K190783 | 000 |
| 06950940801875 | K190783 | 000 |
| 06950940802131 | K190783 | 000 |