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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 K252687
Device Name Manual Wheelchair (HM305-Air1, HM305-Air2)
Applicant
Suzhou Master Machinery Manufacturing Co.,Ltd
# 379,Jujin Rd., Zhangpu Town
Kunshan,  CN
Applicant Contact Wu Hongying
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
14th Floor, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Xiang Shouqiu
Regulation Number890.3850
Classification Product Code
IOR  
Date Received08/26/2025
Decision Date 11/21/2025
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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