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 Electrode, Cutaneous
510(k) Number K161282
Device Name FlexStim Neurostimulation Electrodes Model Numbers: 5050ROC1S, 5050ROC1W, 5050ROC2S, 5050ROC2W, 5050SQC1S, 5050SQC1W, 5050SQC2S, 5050SQC2W
Applicant
Medico Electrodes International , Ltd.
Plot 142a/Aa, 12, 27, 28 & 29, Noida Special Economic Zone
Noida,  IN 201305
Applicant Contact AMIT SETH
Correspondent
Medico Electrodes International , Ltd.
Plot 142a/Aa, 12, 27, 28 & 29, Noida Special Economic Zone
Noida,  IN 201305
Correspondent Contact AMIT SETH
Regulation Number882.1320
Classification Product Code
GXY  
Date Received05/06/2016
Decision Date 10/30/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-