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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 K242615
Device Name Intermittent pressure compression system (Compression Pump PT1005A; Leg Compression Cuffs; L-1001S, L-1001L, L-1001XL, L-1001XXL, L-1001XXXL)
Applicant
Xiamen Taotao Technology Co., Ltd.
Unit 1309, # 120, Xinyuan Rd., Haicang District
Xiamen City,  CN 361000
Applicant Contact Chunshui Ma
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Kiwi Xu
Regulation Number890.5650
Classification Product Code
IRP  
Date Received09/03/2024
Decision Date 07/23/2025
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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