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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 K240255
Device Name Electric Wheelchair (JLE-W01A-2023)
Applicant
Zhejiang Jianrui Technology Company Limited
Rm. 3 To 5 From The N. Of Bldg. 7,
# 28 Jinshan W. Rd., Yongkang Economic Development Zone
Jinhua,  CN
Applicant Contact Zhihong Lyu
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Jarvis Wu
Regulation Number890.3860
Classification Product Code
ITI  
Date Received01/31/2024
Decision Date 08/07/2024
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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