• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
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 K121719
Device Name SM TENS & PMS
Original Applicant
HONG QIANGXING (SHEN ZHEN) ELECTRONICS LIMITED
room 1706, no. 128 songle rd
songjiang area
shanghai,  CH 201600
Original Contact doris dong
Regulation Number890.5850
Classification Product Code
NGX  
Subsequent Product Code
NUH  
Date Received06/11/2012
Decision Date 05/10/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Physical Medicine
Review Advisory Committee Physical Medicine
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-