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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 K230167
Device Name BACK 4
Applicant
Swims America Corp
1133 Westchester Ave. Suite N 220
White Plains,  NY  10604
Applicant Contact Matthieu Commeau
Correspondent
Swims America Corp
1133 Westchester Ave. Suite N 220
White Plains,  NY  10604
Correspondent Contact Matthieu Commeau
Regulation Number890.5850
Classification Product Code
IPF  
Subsequent Product Code
PBX  
Date Received01/20/2023
Decision Date 09/14/2023
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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