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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Components, Wheelchair
510(k) Number K211919
Device Name KISS Dynamic Back Support, KISS Dynamic Solid Drop Seat
Applicant
Kinetic Innovative Seating System, LLC
26 N. Main St., Office Bldg
Branford,  CT  06405
Applicant Contact Susan Farricielli
Correspondent
Kinetic Innovative Seating System, LLC
26 N. Main St., Office Bldg
Branford,  CT  06405
Correspondent Contact Susan Farricielli
Regulation Number890.3920
Classification Product Code
KNN  
Date Received06/21/2021
Decision Date 03/04/2022
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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