K202725 is an FDA 510(k) clearance for the ETD4000. This device is classified as a Interferential Current Therapy (Class II - Special Controls, product code LIH).
Submitted by Therasigma, LLC (Washougal, US). The FDA issued a Cleared decision on March 26, 2021, 190 days after receiving the submission on September 17, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K202725 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 17, 2020 |
| Decision Date | March 26, 2021 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Statement |
| Product Code | LIH - Interferential Current Therapy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |