Cleared Special

CoolTone

K251378 · Zimmer Medizinsysteme GmbH · Physical Medicine

Jul 2025

Decision

73d

Days

Class 2

Risk

About This 510(k) Submission

K251378 is an FDA 510(k) clearance for the CoolTone, a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II — Special Controls, product code NGX), submitted by Zimmer Medizinsysteme GmbH (Neu-Elm, DE). The FDA issued a Cleared decision on July 14, 2025, 73 days after receiving the submission on May 2, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K251378 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2025
Decision Date	July 14, 2025
Days to Decision	73 days
Submission Type	Special
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	NGX — Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 890.5850
Definition	A Powered Muscle Stimulator For Muscle Conditioning Is A Device Used For Other Than Medical Purposes To Apply An Electrical Current To Electrodes On A Person's Skin To Temporarily Affect The Stimulated Muscle's Contractile Properties, Force Output, And/or Fatigue Resistance. Unlike The Classified Powered Muscle Stimulator Devices Intended For Use In Physical Medicine And Rehabilitation, This Device Is Not Intended For Use In Patients With Medical Conditions And Is Intended Only For Muscle Conditioning Purposes.