The following data is part of a premarket notification filed by Shenzhen Osto Technology Co., Ltd. with the FDA for Intelligent Wireless Fitness Apparatus (model: Ast-301, Ast-302, Ast-303).
| Device ID | K182136 |
| 510k Number | K182136 |
| Device Name: | Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Shenzhen OSTO Technology Co., Ltd. No.43 Longfeng Road, Xinsheng Community Shenzhen, CN |
| Contact | Li Yang |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park 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 | 2018-08-06 |
| Decision Date | 2019-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06950940801158 | K182136 | 000 |
| 06950940801417 | K182136 | 000 |