K202337 is an FDA 510(k) clearance for the Pulsed electromagnetic field wrap. This device is classified as a Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat (Class II - Special Controls, product code ILX).
Submitted by Hi-Dow International, Inc. (Maryland Heights, US). The FDA issued a Cleared decision on December 15, 2020, 120 days after receiving the submission on August 17, 2020.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5290.
| 510(k) Number | K202337 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 17, 2020 |
| Decision Date | December 15, 2020 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Statement |
| Product Code | ILX — Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5290 |