The following data is part of a premarket notification filed by Tenscare Ltd. with the FDA for Tenscare Kegelfit.
| Device ID | K142506 |
| 510k Number | K142506 |
| Device Name: | TensCare KegelFit |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | TENSCARE LTD. 9 BLENHEIM ROAD Epsom, GB Kt19 9be |
| Contact | Andrew Brown |
| Correspondent | Linda Stamschor Akos (Meddiquest) 17967 615th Street Kellogg, MN 55945 |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-08 |
| Decision Date | 2015-04-20 |
| Summary: | summary |