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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Standup
510(k) Number K102734
Device Name COMFORT STANDING WHEELCHAIR, HERO SERIES
Applicant
Comfort Orthopedic Co., Ltd.
2064, Tamarin Dr.,
Columbus,  OH  43235
Applicant Contact JEN KE-MIN
Correspondent
Comfort Orthopedic Co., Ltd.
2064, Tamarin Dr.,
Columbus,  OH  43235
Correspondent Contact JEN KE-MIN
Regulation Number890.3900
Classification Product Code
IPL  
Date Received09/22/2010
Decision Date 12/14/2010
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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