K092448 is an FDA 510(k) clearance for the HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Hivox Biotek, Inc. (Taipei Hsien, TW). The FDA issued a Cleared decision on March 30, 2010, 232 days after receiving the submission on August 10, 2009.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K092448 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2009 |
| Decision Date | March 30, 2010 |
| Days to Decision | 232 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 |