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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 K130982
Device Name LERADO, POWER WHEELCHAIR
Applicant
Lerado Global (Macao Commercial Offshore) Limited
Avenida Marciano Baotista, # 26-54b, 7 Andar
H7 Edif. Centro Com. Chong Fok
Macau,  CN CH
Applicant Contact JEN KE-MIN
Correspondent
Lerado Global (Macao Commercial Offshore) Limited
Avenida Marciano Baotista, # 26-54b, 7 Andar
H7 Edif. Centro Com. Chong Fok
Macau,  CN CH
Correspondent Contact JEN KE-MIN
Regulation Number890.3860
Classification Product Code
ITI  
Date Received04/09/2013
Decision Date 02/28/2014
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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