Cleared Traditional

VMAT PRO

K243488 · Termosalud · Physical Medicine
Feb 2025
Decision
86d
Days
Class 1
Risk

About This 510(k) Submission

K243488 is an FDA 510(k) clearance for the VMAT PRO, a Massager, Therapeutic, Electric (Class I — General Controls, product code ISA), submitted by Termosalud (Gijon, ES). The FDA issued a Cleared decision on February 6, 2025, 86 days after receiving the submission on November 12, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5660.

Submission Details

510(k) Number K243488 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2024
Decision Date February 06, 2025
Days to Decision 86 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code ISA — Massager, Therapeutic, Electric
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5660

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