K060236 is an FDA 510(k) clearance for the MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODE. 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 March 31, 2006, 60 days after receiving the submission on January 30, 2006.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K060236 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2006 |
| Decision Date | March 31, 2006 |
| Days to Decision | 60 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 |