The following data is part of a premarket notification filed by Shenzhen Osto Technology Company Limited with the FDA for Neck Care Therapy, Model: Ast-905a, Ast-905d, Ast-905h.
| Device ID | K210756 |
| 510k Number | K210756 |
| Device Name: | Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H |
| 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 | Li Yang Guangzhou GLOMED Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, CN 510663 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-15 |
| Decision Date | 2021-06-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06950940801646 | K210756 | 000 |
| 06950940801745 | K210756 | 000 |
| 06950940801783 | K210756 | 000 |