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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 K142783
Device Name HEARTWAY Electrically Powered Wheelchair P27
Applicant
Heartway Medical Products Co., Ltd.
#6, Rd. 25, Taichung Industrial Park
Taichung City,  TW 40850
Applicant Contact JEN KE-MIN
Correspondent
Heartway Medical Products Co., Ltd.
#6, Rd. 25, Taichung Industrial Park
Taichung City,  TW 40850
Correspondent Contact JEN KE-MIN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/26/2014
Decision Date 06/12/2015
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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