Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Massager, Therapeutic, Electric
510(k) Number K240358
Device Name ShockPhysio Mobile (model SW3200 Basic)
Applicant
Shenzhen Dongdixin Technology Co., Ltd.
Floor 1-2, #3 Bldg., Fanshen Xusheng Industrial Estate
Xilixiaobaimang, Nanshan District
Shenzhen,  CN 518108
Applicant Contact Yuan Siping
Correspondent
Shenzhen Dongdixin Technology Co., Ltd.
Floor 1-2, #3 Bldg., Fanshen Xusheng Industrial Estate
Xilixiaobaimang, Nanshan District
Shenzhen,  CN 518108
Correspondent Contact Yuan Siping
Regulation Number890.5660
Classification Product Code
ISA  
Date Received02/06/2024
Decision Date 06/05/2024
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
-
-