K053434 is an FDA 510(k) clearance for the MYOTRAC INFINITI ELECTRICAL STIMULATOR. This device is classified as a Stimulator, Electrical, Non-implantable, For Incontinence (Class II - Special Controls, product code KPI).
Submitted by Thought Technology , Ltd. (Montreal, Quebec, CA). The FDA issued a Cleared decision on March 15, 2006, 96 days after receiving the submission on December 9, 2005.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5320.
| 510(k) Number | K053434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 09, 2005 |
| Decision Date | March 15, 2006 |
| Days to Decision | 96 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 |