Cleared Traditional

Legend Pro DMA

K200545 · Pollogen, Ltd. · Neurology

Oct 2021

Decision

597d

Days

Class 2

Risk

About This 510(k) Submission

K200545 is an FDA 510(k) clearance for the Legend Pro DMA, a Stimulator, Muscle, Powered, For Muscle Conditioning (Class II — Special Controls, product code NGX), submitted by Pollogen, Ltd. (Tel Aviv, IL). The FDA issued a Cleared decision on October 21, 2021, 597 days after receiving the submission on March 3, 2020. This device falls under the Neurology review panel. Regulated under 21 CFR 890.5850.

Submission Details

510(k) Number	K200545 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 03, 2020
Decision Date	October 21, 2021
Days to Decision	597 days
Submission Type	Traditional
Review Panel	Neurology (NE)
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.