K082377 is an FDA 510(k) clearance for the TENSCARE ITOUCH MODEL(S) EASY AND PLUS. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Tenscare, Ltd. (Epsom, GB). The FDA issued a Cleared decision on February 9, 2009, 175 days after receiving the submission on August 18, 2008.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K082377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 2008 |
| Decision Date | February 09, 2009 |
| Days to Decision | 175 days |
| Submission Type | Abbreviated |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | GZJ - Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |