K242041 is an FDA 510(k) clearance for the STOPWET iontophoresis apparatus (SW01). This device is classified as a Device, Iontophoresis, Other Uses (Class II - Special Controls, product code EGJ).
Submitted by Taiwan Medical Electronics Co., Ltd. (Taipei City, TW). The FDA issued a Cleared decision on April 1, 2025, 263 days after receiving the submission on July 12, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K242041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 12, 2024 |
| Decision Date | April 01, 2025 |
| Days to Decision | 263 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 |