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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 K231750
Device Name MA012 Aluminum wheelchair, MS019 steel wheelchair
Applicant
Sichuan Ast Medical Equipment Co., Ltd.
#58 Jinpeng Rd., Area C, W. Industrial Park,
Luxian County
Luzhou,  CN 646100
Applicant Contact Mae Tse
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Regulation Number890.3850
Classification Product Code
IOR  
Date Received06/15/2023
Decision Date 08/15/2023
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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