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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 K082784
Device Name JUMAO MANUAL WHEELCHAIR
Applicant
Danyang Jumao Healthcare Equipment Co., Ltd.
#89 Shuangfeng Rd.,
Jiepai Town
Danyang; Jiangsu,  CN 212323
Applicant Contact QING WANG
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number890.3850
Classification Product Code
IOR  
Date Received09/23/2008
Decision Date 10/07/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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