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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 K260948
Device Name Air Compression Massager (EP30B001 I)
Applicant
Wavepulse (Xiamen) Healthcare Technology Co., Ltd.
5/F-1,881 Tonglong 2nd Rd., Xiangan District,Xiamen Torch Hi
Xiamen,  CN 361021
Applicant Contact Jie Wang
Correspondent
Shanghai SUNGO Management Consulting Co., Ltd.
Rm. 1401, Dongfang Bldg., 1500# Century Ave.
Shanghai,  CN 200122
Correspondent Contact Andrew Wang
Regulation Number890.5650
Classification Product Code
IRP  
Date Received03/23/2026
Decision Date 07/24/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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