K970429 is an FDA 510(k) clearance for the BIOSCOPE SD TENS, ARISTA SD PLUS, AP-102080T. This device is classified as a Stimulator, Nerve, Transcutaneous, For Pain Relief (Class II - Special Controls, product code GZJ).
Submitted by Apex Medical Corp. (Shi-Chih, Taipei Hsien, TW). The FDA issued a Cleared decision on April 29, 1997, 84 days after receiving the submission on February 4, 1997.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K970429 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 1997 |
| Decision Date | April 29, 1997 |
| Days to Decision | 84 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 |