K844213 is an FDA 510(k) clearance for the STIMTECH SD PATIENT 6089 #78-8050. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Codman & Shurtleff, Inc. (Randolph, US). The FDA issued a Cleared decision on January 10, 1985, 71 days after receiving the submission on October 31, 1984.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K844213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 31, 1984 |
| Decision Date | January 10, 1985 |
| Days to Decision | 71 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 |