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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wheelchair, Powered
510(k) Number K241603
Device Name Powered Wheelchair (NXN20-208, NXN20-211)
Applicant
Zhejiang Nysin Medical Co., Ltd.
Bldg. 13, # 305 Jiulong N. Rd., Dongcheng District,
Yongkang
Jinhua,  CN 321300
Applicant Contact Zhang Xiaoying
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received06/04/2024
Decision Date 11/20/2024
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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