Cleared Traditional

Curapuls 670

K243112 · Enraf-Nonius, B.V. · Physical Medicine
Jun 2025
Decision
268d
Days
Class 2
Risk

About This 510(k) Submission

K243112 is an FDA 510(k) clearance for the Curapuls 670, 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 review panel. Regulated under 21 CFR 890.5290.

Submission Details

510(k) Number K243112 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code IMJ — Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5290