The following data is part of a premarket notification filed by Shenzhen As Tec Technology Co., Ltd with the FDA for Tens And Muscle Stimulator.
| Device ID | K200727 |
| 510k Number | K200727 |
| Device Name: | TENS And Muscle Stimulator |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Shenzhen As Tec Technology Co., Ltd 8E XinBaoYi Industrial Bld, Houting Village, Beiting Road, Shajing Shenzhen, CN 518012 |
| Contact | Connie Li |
| Correspondent | Doris Dong Shanghai CV Technology Co., Ltd Room 903, No. 19 Dongbao Road, Songjiang Area Shanghai, CN 201613 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-20 |
| Decision Date | 2020-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970890320363 | K200727 | 000 |
| 06970890320356 | K200727 | 000 |
| 06970890320547 | K200727 | 000 |
| 06970890320530 | K200727 | 000 |
| 06970890320493 | K200727 | 000 |
| 06970890320486 | K200727 | 000 |