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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 K233006
Device Name MyndMove, MyndMove 2.0
Applicant
Myndtec, Inc.
1900 Minnesota Ct.
Mississauga,  CA L5N 3C9
Applicant Contact Yesmil Pena
Correspondent
Myndtec, Inc.
1900 Minnesota Ct.
Mississauga,  CA L5N 3C9
Correspondent Contact Yesmil Pena
Regulation Number882.5810
Classification Product Code
GZI  
Subsequent Product Code
IPF  
Date Received09/22/2023
Decision Date 06/25/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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