Cleared Special

CoolTone

K192940 · Zimmer Medizinsysteme GmbH · Physical Medicine

Nov 2019

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K192940 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-Ulm, DE). The FDA issued a Cleared decision on November 15, 2019, 28 days after receiving the submission on October 18, 2019. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K192940 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 18, 2019
Decision Date	November 15, 2019
Days to Decision	28 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.