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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 K220156
Device Name Electrically Powered Wheelchair, Joy Rider
Applicant
Tung Keng Enterprise Co., Ltd.
# 1, Lane 160, Sec. 2, Tan-Fu Rd., Tan-Tzu Dist.,
Taichung City,  CN
Applicant Contact Jen Ke-Min
Correspondent
Roc Chinese-European Industrial Research Society
# 58, Fu Chiun St.
Hsin Chu City,  TW 30067
Correspondent Contact Jen Ke-Min
Regulation Number890.3860
Classification Product Code
ITI  
Date Received01/19/2022
Decision Date 10/07/2022
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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