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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 K252829
Device Name Powered Wheelchair (PL001-9001)
Applicant
Suzhou KD Intelligent Device Co., Ltd.
#36, Gugang Rd.
Chengxiang Town
Taicang City,  CN 215400
Applicant Contact Zhongying Xia
Correspondent
Irc USA
2950 E Lindrick Dr.
Chandler,  AZ  85249
Correspondent Contact Charles Mack
Regulation Number890.3860
Classification Product Code
ITI  
Date Received09/05/2025
Decision Date 11/12/2025
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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