• 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, nerve, transcutaneous, for pain relief
510(k) Number K113544
Model PL009 PL009A PL029
Device Name ELECTRONIC PULSE MASSAGER TENS ELECTRONIC PULSE MASSAGER
Original Applicant
PROSPERA CORPORATION
405 boulder ct
suite 500
pleasanton,  CA  94566
Original Contact kevin walls
Regulation Number882.5890
Classification Product Code
GZJ  
Date Received12/01/2011
Decision Date 07/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Neurology
Review Advisory Committee Neurology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-