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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Neuromuscular, External Functional
510(k) Number K170564
Device Name MyndMove System, MyndMove Functional Electrical Stimulator
Applicant
Myndtec, Inc.
2233 Argentia Rd.
Suite 307
Mississauga,  CA L5N 2X7
Applicant Contact Alexa Granger
Correspondent
Myndtec, Inc.
2233 Argentia Rd.
Suite 307
Mississauga,  CA L5N 2X7
Correspondent Contact Alexa Granger
Regulation Number882.5810
Classification Product Code
GZI  
Subsequent Product Code
IPF  
Date Received02/27/2017
Decision Date 08/30/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Clinical Trials NCT02266836
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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