Cleared Traditional

Compact II

K251083 · Enraf-Nonius, B.V. · Physical Medicine
Sep 2025
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K251083 is an FDA 510(k) clearance for the Compact II, a Stimulator, Muscle, Powered (Class II — Special Controls, product code IPF), submitted by Enraf-Nonius, B.V. (Rotterdam, NL). The FDA issued a Cleared decision on September 12, 2025, 156 days after receiving the submission on April 9, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number K251083 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2025
Decision Date September 12, 2025
Days to Decision 156 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IPF — Stimulator, Muscle, Powered
Device Class Class II — Special Controls
CFR Regulation 21 CFR 890.5850