The following data is part of a premarket notification filed by Shenzhen Konmed Technology Co., Ltd. with the FDA for Pelvifine Pelvic Muscle Trainer.
| Device ID | K163288 |
| 510k Number | K163288 |
| Device Name: | Pelvifine Pelvic Muscle Trainer |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | Shenzhen Konmed Technology Co., Ltd. 703B, Haide Building A, Nanxin Road, Nanshan Shenzhen, CN 518000 |
| Contact | Tony Tony |
| Correspondent | Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Suite 306, Kecheng Mansion, No.121 Science Road Guangzhou Science Park Guangzhou, CN 510663 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-22 |
| Decision Date | 2018-01-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970935830017 | K163288 | 000 |