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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 K222924
Device Name Leg Massager RF-ALM070
Applicant
Shenzhen Ruiyi Business Technology Co., Ltd.
Qianhai Complex A201, Qianwan Rd. 1, Qianhai, Shenzhen-Hong
Cooperation Zone
Shenzhen,  CN 518000
Applicant Contact Jacky Li
Correspondent
Shanghai Spica Management Consulting Co., Ltd.
609 Rm., # 133 Shengang Ave., Pudong New District
Shanghai,  CN 201306
Correspondent Contact Libray Zhang
Regulation Number890.5650
Classification Product Code
IRP  
Date Received09/26/2022
Decision Date 12/23/2022
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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