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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K223527
Device Name Little Wave Clik, Rogue XP, Little Wave XP, Spark
Applicant
Ki Mobility, LLC
5201 Woodward Dr.
Stevens Point,  WI  54481
Applicant Contact Mark Murphy
Correspondent
Ki Mobility, LLC
5201 Woodward Dr.
Stevens Point,  WI  54481
Correspondent Contact Mark Murphy
Regulation Number890.3850
Classification Product Code
IOR  
Subsequent Product Code
KNO  
Date Received11/23/2022
Decision Date 08/31/2023
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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