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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Powered Inflatable Tube
510(k) Number K251662
Device Name Air Compression Therapy Device (ST-504); Air Compression Therapy Device (ST-505); Air Compression Therapy Device (ST-506); Air Compression Therapy Device (ST-507)
Applicant
Shenzhen Future Electronic Co., Ltd.
201,Bldg. B,#30 Youtian Rd.,Anliang Community,
Yuanshan St.,Longgang District
Shenzhen,  CN
Applicant Contact Xiongxiu Zhou
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co.Ltd
Rm. 1509, Jingting Bldg.,Dongzhou Community
Guangming St.,Guangming District
Shenzhen,  CN 518107
Correspondent Contact Xiongxiu Zhou
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Codes
IRO   IRT  
Date Received05/30/2025
Decision Date 11/13/2025
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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