K011543 is an FDA 510(k) clearance for the TENS CARE, MODEL XL-Y3. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Tenscare, Ltd. (Timperley, Cheshire, GB). The FDA issued a Cleared decision on August 31, 2001, 105 days after receiving the submission on May 18, 2001.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K011543 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2001 |
| Decision Date | August 31, 2001 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| 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 |