The following data is part of a premarket notification filed by Tenscare Ltd. with the FDA for Tenscare Itouch Sure Model Its.
| Device ID | K103698 |
| 510k Number | K103698 |
| Device Name: | TENSCARE ITOUCH SURE MODEL ITS |
| Classification | Stimulator, Electrical, Non-implantable, For Incontinence |
| Applicant | TENSCARE LTD. 9 BLENHEIM ROAD Epsom, Surrey, GB Kt19 9be |
| Contact | Andrew Brown |
| Correspondent | Andrew Brown TENSCARE LTD. 9 BLENHEIM ROAD Epsom, Surrey, GB Kt19 9be |
| Product Code | KPI |
| CFR Regulation Number | 876.5320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-20 |
| Decision Date | 2011-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05033435070039 | K103698 | 000 |