K232020 is an FDA 510(k) clearance for the Iontophoresis Electrodes. This device is classified as a Device, Iontophoresis, Other Uses (Class II - Special Controls, product code EGJ).
Submitted by Top-Rank Health Care Co., Ltd. (Shaoxing, CN). The FDA issued a Cleared decision on October 16, 2023, 101 days after receiving the submission on July 7, 2023.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5525.
| 510(k) Number | K232020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 07, 2023 |
| Decision Date | October 16, 2023 |
| Days to Decision | 101 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 |