K021952 is an FDA 510(k) clearance for the HIVOX DREAMATE DM-800. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Hivox Biotek, Inc. (Hsin-Chu City, TW). The FDA issued a Cleared decision on May 2, 2003, 323 days after receiving the submission on June 13, 2002.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K021952 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2002 |
| Decision Date | May 02, 2003 |
| Days to Decision | 323 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | GZJ - Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |