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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Massager, Vacuum, Radio Frequency Induced Heat
510(k) Number K252288
Device Name TECAR Therapy Device (TC2000, TC2001)
Applicant
Shenzhen Dongdixin Technology Co., Ltd.
Floor 1-2, #3 Bldg., Fanshen Xusheng Industrial Estate
Xilixiaobaimang, Nanshan District
Shenzhen,  CN 518108
Applicant Contact Siping Yuan
Correspondent
Shenzhen Dongdixin Technology Co., Ltd.
Floor 1-2, #3 Bldg., Fanshen Xusheng Industrial Estate
Xilixiaobaimang, Nanshan District
Shenzhen,  CN 518108
Correspondent Contact Siping Yuan
Regulation Number878.4400
Classification Product Code
PBX  
Date Received07/23/2025
Decision Date 10/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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