The following data is part of a premarket notification filed by Shenzhen Kentro Medical Electronics Co., Ltd with the FDA for Low-frequency Multi-function Physiotherapy Instrument.
| Device ID | K200177 |
| 510k Number | K200177 |
| Device Name: | Low-frequency Multi-function Physiotherapy Instrument |
| 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 | 2021-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06924607702461 | K200177 | 000 |
| 06924607702331 | K200177 | 000 |
| 06924607702348 | K200177 | 000 |
| 06924607702355 | K200177 | 000 |
| 06924607702362 | K200177 | 000 |
| 06924607702379 | K200177 | 000 |
| 06924607702386 | K200177 | 000 |
| 06924607702409 | K200177 | 000 |
| 06924607702416 | K200177 | 000 |
| 06924607702423 | K200177 | 000 |
| 06924607702478 | K200177 | 000 |
| 06924607702393 | K200177 | 000 |
| 06924607702430 | K200177 | 000 |
| 06924607702447 | K200177 | 000 |
| 06924607702454 | K200177 | 000 |
| 10810113573790 | K200177 | 000 |