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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 K240373
Device Name Air compression Leg Massager (MM0520, MM0521, MM0522)
Applicant
Zhangzhou Easepal Medical Science and Technology Co., Ltd.
West Of The 4th Floor, # 7 Bldg., Easepal Factory,
# 228 Jiaosong Rd., Jiaomei Town,
Zhangzhou,  CN
Applicant Contact Yuehua Huang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Eva Li
Regulation Number890.5650
Classification Product Code
IRP  
Subsequent Product Code
ILO  
Date Received02/07/2024
Decision Date 09/17/2024
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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