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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 K260121
Device Name Manual Wheelchair (7101L, 7102LHD)
Applicant
Foshan Nanhai Hongchen Medical Equipment Co., Ltd.
Factory F, # 2, Nansha Rd., Nansha Community
Danzao Town, Nanhai District, Foshan City
Foshan,  CN 528000
Applicant Contact Jinghan Tang
Correspondent
Foshan Nanhai Hongchen Medical Equipment Co., Ltd.
Factory F, # 2, Nansha Rd., Nansha Community
Danzao Town, Nanhai District, Foshan City
Foshan,  CN 528000
Correspondent Contact Jinghan Tang
Regulation Number890.3850
Classification Product Code
IOR  
Date Received01/15/2026
Decision Date 04/28/2026
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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