K243112 is an FDA 510(k) clearance for the Curapuls 670. This device is classified as a Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat (Class II - Special Controls, product code IMJ).
Submitted by Enraf-Nonius, B.V. (Rotterdam, NL). The FDA issued a Cleared decision on June 25, 2025, 268 days after receiving the submission on September 30, 2024.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5290.
| 510(k) Number | K243112 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2024 |
| Decision Date | June 25, 2025 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | IMJ - Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5290 |