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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 K250576
Device Name Flexx Junior (FLX-J00, FLX-J50)
Applicant
Karma Mobility Co, Ltd.
30 Moo 7 Tambol Khamtaleso Amphur (Korat)
Khamthleso,  TH 30280
Applicant Contact Anoohya Pulipaka
Correspondent
Karma Mobility Co, Ltd.
30 Moo 7 Tambol Khamtaleso Amphur (Korat)
Khamthleso,  TH 30280
Correspondent Contact Anoohya Pulipaka
Regulation Number890.3850
Classification Product Code
IOR  
Subsequent Product Code
LBE  
Date Received02/27/2025
Decision Date 11/04/2025
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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