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 (model: Ktr-2230, Ktr-2220, Ktr-2210, Ktr-2231, Ktr-2221, Ktr-2211, Ktr-2232, Ktr-2222, Ktr-2212).
| Device ID | K191982 |
| 510k Number | K191982 |
| Device Name: | Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) |
| 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 | 2019-07-25 |
| Decision Date | 2020-09-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06924607702324 | K191982 | 000 |
| 06924607702317 | K191982 | 000 |
| 06924607702300 | K191982 | 000 |
| 06924607702294 | K191982 | 000 |
| 06924607702287 | K191982 | 000 |
| 06924607702270 | K191982 | 000 |
| 06924607702263 | K191982 | 000 |
| 06924607702256 | K191982 | 000 |
| 06924607702249 | K191982 | 000 |