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, nerve, transcutaneous, over-the-counter
510(k) Number K150277
Device Name Pain Therapy System, Model PTS-II
Applicant
COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD
2ND &3RD FLOOR, BLD. 6,
DAPIAN INDUSTRIAL ZONE, TANGZIA RD., TIANHE DISTRICT
GUANGZHOU,  CN 510665
Applicant Contact Eagle Eagle
Correspondent
MEDIA TRADE CORPORATION
11820 RED HIBISCUS DRIVE
BONITA SPRINGS,  FL  34135
Correspondent Contact GUENTER GINSBERG
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
GZJ   NGX   NYN  
Date Received02/05/2015
Decision Date 02/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-