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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 K202506
Device Name Karma Powered Wheelchair
Applicant
Karma Medical Products Co., Ltd.
# 2363, Sec. 2, University Rd., Min-Hsiung Shiang
Chia Yi,  CN 62144
Applicant Contact Ke-Min Jen
Correspondent
Chinese-European Industrial Research Society
# 58, Fu-Chiun St.
Hsin-Chu City,  CN 30067
Correspondent Contact Ke-Min Jen
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/31/2020
Decision Date 04/19/2021
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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