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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 K973491
Device Name MECHANICAL FOLDING WHEEL CHAIR
Applicant
Heartway Medical Products Co., Ltd.
Rd. 5, # 4,
Taichung Industrial Park
Taichung,  TW
Applicant Contact KENNY HO
Correspondent
Heartway Medical Products Co., Ltd.
Rd. 5, # 4,
Taichung Industrial Park
Taichung,  TW
Correspondent Contact KENNY HO
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/15/1997
Decision Date 12/04/1997
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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