The following data is part of a premarket notification filed by Shenzhen Med-link Electronics Tech Co, Ltd with the FDA for Incontinence Probe.
| Device ID | K210441 |
| 510k Number | K210441 |
| Device Name: | Incontinence Probe |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | Shenzhen Med-link Electronics Tech Co, Ltd 4th And 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community Dalang Street Shenzhen, CN 518109 |
| Contact | Yongfen Yang |
| Correspondent | Yongfen Yang Shenzhen Med-link Electronics Tech Co, Ltd 4th And 5th Floor, Building Two, Hualian Industrial Zone, Xinshi Community Dalang Street Shenzhen, CN 518109 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-12 |
| Decision Date | 2021-09-17 |