The following data is part of a premarket notification filed by Shenzhen Kentro Medical Electronics Co., Ltd with the FDA for Transcutaneous Electronic Nerve Stimulator.
| Device ID | K200237 |
| 510k Number | K200237 |
| Device Name: | Transcutaneous Electronic Nerve Stimulator |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Shenzhen Kentro Medical Electronics Co., Ltd No.3, Xihu Industry Zone, Xikeng Village, Henggang Town Longgang District, Shenzhen City, CN 518115 |
| Contact | Zewu Zhang |
| 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 | 2020-01-24 |
| Decision Date | 2020-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10810041985702 | K200237 | 000 |
| 06924607702492 | K200237 | 000 |
| 06924607702508 | K200237 | 000 |
| 06924607702515 | K200237 | 000 |
| 06924607702522 | K200237 | 000 |
| 06924607702539 | K200237 | 000 |
| 06924607702546 | K200237 | 000 |
| 06924607702553 | K200237 | 000 |
| 06924607702560 | K200237 | 000 |
| 06924607702577 | K200237 | 000 |
| 06924607702607 | K200237 | 000 |
| 06924607702614 | K200237 | 000 |
| 06924607702485 | K200237 | 000 |