BionicGym Powered Muscle Stimulator— 510(k) K182794

Name: FDA 510(k) clearance K182794
Creator: U.S. Food and Drug Administration
Published: 2019-07-18

Substantially Equivalent

Medical Currents, Ltd.

FDA 510(k) clearance K182794 for BionicGym Powered Muscle Stimulator, Substantially Equivalent on 2019-07-18. Applicant: Medical Currents, Ltd.. Device class: 2.

Clearance details

Applicant: Medical Currents, Ltd.
Product code: Code NGX
Device class: Class 2
Regulation: 21 CFR 890.5850
Advisory panel: Physical Medicine
Date received: 2018-10-01
Decision date: 2019-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin 2, IE

Download summary PDF View on FDA.gov ↗

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