K922020 is an FDA 510(k) clearance for the ENDOMED 582. This device is classified as a Interferential Current Therapy (Class II - Special Controls, product code LIH).
Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on September 22, 1992, 145 days after receiving the submission on April 30, 1992.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K922020 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 30, 1992 |
| Decision Date | September 22, 1992 |
| Days to Decision | 145 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 |