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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Muscle, Powered
510(k) Number K233098
Device Name MYOTouch Muscle Stimulator
Applicant
Sunmed, LLC
2710 Northridge Dr. NW
Suite A
Grand Rapids,  MI  49544
Applicant Contact Robert Yamashita
Correspondent
Sunmed, LLC
2710 Northridge Dr. NW
Suite A
Grand Rapids,  MI  49544
Correspondent Contact Robert Yamashita
Regulation Number890.5850
Classification Product Code
IPF  
Date Received09/26/2023
Decision Date 08/02/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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