MYGAIT STIMULATION SYSTEM— 510(k) K141812

Name: FDA 510(k) clearance K141812
Creator: U.S. Food and Drug Administration
Published: 2015-04-02

Substantially Equivalent

Otto Bock Healthcare Products GmbH

FDA 510(k) clearance K141812 for MYGAIT STIMULATION SYSTEM, Substantially Equivalent on 2015-04-02. Applicant: Otto Bock Healthcare Products GmbH. Device class: 2.

Clearance details

Applicant: Otto Bock Healthcare Products GmbH
Product code: Code GZI
Device class: Class 2
Regulation: 21 CFR 882.5810
Advisory panel: Neurology
Date received: 2014-07-07
Decision date: 2015-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vienna, AT

Download summary PDF View on FDA.gov ↗

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