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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 K242402
Device Name Power wheelchair
Applicant
Zhejiang Zhonglei Medical Technology Co. , Ltd.
1st Floor, 2nd Floor, # 66, Dayuan St.
Nanmingshan St., Liandu District
Lishui,  CN
Applicant Contact Chengwei Ying
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Ariel Xiang
Regulation Number890.3860
Classification Product Code
ITI  
Date Received08/13/2024
Decision Date 11/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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