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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K242430
Device Name Power-Flex (PFX1214); Power-Flex (PFX1517); Power-Flex (PFX1820)
Applicant
Soul Mobility
659 River Bluff Cir.
Oconomowoc,  WI  53066
Applicant Contact Troy Tesmer
Correspondent
Spectramedex, LLC
3215 Golf Rd. #149
Delafield,  WI  53018
Correspondent Contact John Ziobro
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/15/2024
Decision Date 11/12/2024
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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