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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 K260849
Device Name ICON 35; ICON 45; ICON 60; ICON 30FAF
Applicant
Rehasense USA, Inc.
1208 N. Independence Blvd. Romeoville, Il 60446
Romeoville,  IL  60446
Applicant Contact Matthew P Fitman
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave., Shanghai 20012
Shanghai,  CN
Correspondent Contact Eva Li
Regulation Number890.3850
Classification Product Code
IOR  
Date Received03/16/2026
Decision Date 06/11/2026
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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