Cleared Traditional

FitRelief TENS&EMS Wireless Device

K191938 · Heat IN A Click, LLC · Neurology

Aug 2020

Decision

406d

Days

Class 2

Risk

About This 510(k) Submission

K191938 is an FDA 510(k) clearance for the FitRelief TENS&EMS Wireless Device, a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II — Special Controls, product code NGX), submitted by Heat IN A Click, LLC (Dania, US). The FDA issued a Cleared decision on August 28, 2020, 406 days after receiving the submission on July 19, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K191938 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2019
Decision Date	August 28, 2020
Days to Decision	406 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Statement

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.