• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name stimulator, muscle, powered, for muscle conditioning
510(k) Number K122393
Device Name TG-BODY MI&BODY S-TRAINER
Original Applicant
MIGA MEDICAL CO., LTD.
#821 samil plaza
837-26 yeuksam-dong
gangnam-gu,  KR 135-768
Original Contact yang ho dong
Regulation Number890.5850
Classification Product Code
NGX  
Date Received08/07/2012
Decision Date 12/10/2013
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
-
-