K103698 is an FDA 510(k) clearance for the TENSCARE ITOUCH SURE MODEL ITS. This device is classified as a Stimulator, Electrical, Non-implantable, For Incontinence (Class II - Special Controls, product code KPI).
Submitted by Tenscare, Ltd. (Epsom, Surrey, GB). The FDA issued a Cleared decision on June 21, 2011, 183 days after receiving the submission on December 20, 2010.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5320.
| 510(k) Number | K103698 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2010 |
| Decision Date | June 21, 2011 |
| Days to Decision | 183 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KPI - Stimulator, Electrical, Non-implantable, For Incontinence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5320 |