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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 K070433
Device Name LERADO, POWER WHEELCHAIR, PB
Applicant
Lerado China Limited
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Applicant Contact JEN KE-MIN
Correspondent
Lerado China Limited
# 58, Fu-Chiun St.
Hsin-Chu City,  TW 30067
Correspondent Contact JEN KE-MIN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received02/14/2007
Decision Date 03/16/2007
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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