The following data is part of a premarket notification filed by Shenzhen Konmed Technology Co.,ltd. with the FDA for Biofeedback Nerve And Muscle Stimulator.
| Device ID | K220161 |
| 510k Number | K220161 |
| Device Name: | Biofeedback Nerve And Muscle Stimulator |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | Shenzhen Konmed Technology Co.,Ltd. 601, Building B4, Shenchengtou Creative Factory Life Science Park, Julongshan A Road Shenzhen, CN 518118 |
| Contact | ShuiShan Yin |
| Correspondent | Cassie Lee Guangzhou Glomed Biological Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, CN 510530 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-20 |
| Decision Date | 2022-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970935830598 | K220161 | 000 |
| 06970935830581 | K220161 | 000 |
| 06970935830574 | K220161 | 000 |
| 06970935830567 | K220161 | 000 |