MyndMove System, MyndMove Functional Electrical Stimulator— 510(k) K170564

Name: FDA 510(k) clearance K170564
Creator: U.S. Food and Drug Administration
Published: 2017-08-30

Substantially Equivalent

Myndtec, Inc.

FDA 510(k) clearance K170564 for MyndMove System, MyndMove Functional Electrical Stimulator, Substantially Equivalent on 2017-08-30. Applicant: Myndtec, Inc.. Device class: 2.

Clearance details

Applicant: Myndtec, Inc.
Product code: Code GZI
Device class: Class 2
Regulation: 21 CFR 882.5810
Advisory panel: Neurology
Date received: 2017-02-27
Decision date: 2017-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

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