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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Mechanical
510(k) Number K020451
Device Name COMFORT WHEELCHAIRS
Applicant
Comfort Orthopedic Co., Ltd.
# 120 Nan Shiang Tsuen,
Shoei Shang Shiang
Chia-Yi,  TW
Applicant Contact ERIC LEE
Correspondent
Comfort Orthopedic Co., Ltd.
# 120 Nan Shiang Tsuen,
Shoei Shang Shiang
Chia-Yi,  TW
Correspondent Contact ERIC LEE
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/11/2002
Decision Date 03/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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