K961376 is an FDA 510(k) clearance for the SMART-TENS, MODEL 456. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Bio-Medical Research, Ltd. (Laurel, US). The FDA issued a Cleared decision on September 12, 1996, 157 days after receiving the submission on April 8, 1996.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K961376 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 08, 1996 |
| Decision Date | September 12, 1996 |
| Days to Decision | 157 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 |