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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 K243206
Device Name Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6)
Applicant
Sichuan Qianli-Beoka Medical Technology, Inc.
Longtan Industrial Park 2nd Sec, E. 3rd Ring Rd.
Chenghua District
Chengdu,  CN 610052
Applicant Contact Qiuju Cai
Correspondent
Shenzhen Reanny Medical Devices Mgmt Consulting Co., Ltd.
Rm. 1509, Jingting Bldg., Dongzhou Community
Guangming St., Guangming District
Shenzhen,  CN
Correspondent Contact Reanny Wang
Regulation Number890.5650
Classification Product Code
IRP  
Date Received10/01/2024
Decision Date 02/19/2025
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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