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 stimulator, muscle, powered, for muscle conditioning
510(k) Number K232181
Device Name Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)
Applicant
Hebei JT Medical Co., Ltd.
C12 Hegu Industrial Park, Chaoyang Road,
Development Zone ZhuoZhou city
Baoding,  CN 072750
Applicant Contact Karen Liu
Correspondent
Beijing STYH Medical Technology Service Co. Ltd.
No.18, Jianshe Road, Kaixuan Street, Liangxiang Town,
Fangshan District,
Beijing,  CN 102488
Correspondent Contact Gina Lian
Regulation Number890.5850
Classification Product Code
NGX  
Date Received07/24/2023
Decision Date 04/24/2024
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
-
-