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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 K010094
Device Name A & I WHEELCHAIRS
Applicant
Taiwan an I Co., Ltd.
#1 Been Ting Been-Tsuoh
Village, Shi-Koou Shiang
Chia-Yi Shiann,  TW
Applicant Contact ANI HWONG
Correspondent
Taiwan an I Co., Ltd.
#1 Been Ting Been-Tsuoh
Village, Shi-Koou Shiang
Chia-Yi Shiann,  TW
Correspondent Contact ANI HWONG
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/11/2001
Decision Date 02/15/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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