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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 K192658
Device Name Manual Wheelchair
Applicant
Jerry Medical Instrument (Shanghai) Co., Ltd.
Building 12, No. 615 Fengdeng Rd, Malu Town,
Jiading District
Shanghai,  CN 201801
Applicant Contact Jianguo Chen
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
RM.608, No.738, Shangcheng Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/25/2019
Decision Date 04/01/2020
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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