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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 K170517
Device Name Merits Model R106/R136 Rehab Wheelchair
Applicant
Merits Healthcare Industries (Suzhou) Co., Ltd.
#29, Fuzhou Rd.
Taicang City,  CN 215411
Applicant Contact Guangyong Li
Correspondent
Merits Healthcare Industries (Suzhou) Co., Ltd.
#29, Fuzhou Rd.
Taicang City,  CN 215411
Correspondent Contact Guangyong Li
Regulation Number890.3850
Classification Product Code
IOR  
Date Received02/21/2017
Decision Date 11/16/2017
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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