K851511 is an FDA 510(k) clearance for the ACCURATECARE I & ACCURATECARE II. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Sunnex, Inc. (Elk Grove Village, US). The FDA issued a Cleared decision on July 1, 1985, 77 days after receiving the submission on April 15, 1985.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K851511 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 1985 |
| Decision Date | July 01, 1985 |
| Days to Decision | 77 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 |