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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 K031618
Device Name COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2
Applicant
Comfort Orthopedic Co., Ltd.
# 120 Nan Shiang Tsuen,
Shoei Shang Shiang
Chia-Yi,  TW
Applicant Contact ERIC H.C. LEE
Correspondent
Comfort Orthopedic Co., Ltd.
# 120 Nan Shiang Tsuen,
Shoei Shang Shiang
Chia-Yi,  TW
Correspondent Contact ERIC H.C. LEE
Regulation Number890.3900
Classification Product Code
IPL  
Date Received05/23/2003
Decision Date 12/18/2003
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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