K932621 is an FDA 510(k) clearance for the RH-801/GS MODEL TRANSQ(R)1. This device is classified as a Device, Iontophoresis, Other Uses (Class II - Special Controls, product code EGJ).
Submitted by Iomed, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on July 26, 1994, 420 days after receiving the submission on June 1, 1993.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K932621 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 1993 |
| Decision Date | July 26, 1994 |
| Days to Decision | 420 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | EGJ — Device, Iontophoresis, Other Uses |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5525 |