K894549 is an FDA 510(k) clearance for the DYNAPHOR(TM) 101, IONTOPHORESIS DEVICE. This device is classified as a Device, Iontophoresis, Other Uses (Class II - Special Controls, product code EGJ).
Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on February 9, 1990, 204 days after receiving the submission on July 20, 1989.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K894549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Direct De Novo (SESD) |
| Date Received | July 20, 1989 |
| Decision Date | February 09, 1990 |
| Days to Decision | 204 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | EGJ — Device, Iontophoresis, Other Uses |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5525 |