K853992 is an FDA 510(k) clearance for the VALLEY FORGE SCIEN-TENS UNIT & ACCESS. LEAD WIRE &. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Valley Forge Scientific Corp. (Valley Forge, US). The FDA issued a Cleared decision on February 21, 1986, 147 days after receiving the submission on September 27, 1985.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K853992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1985 |
| Decision Date | February 21, 1986 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | — |
| Product Code | GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |