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 K160255
Device Name HBOTC Muscle and Nerve Stimulator
Applicant
HB MEDICAL, INC.
5702 BOLSA AVENUE
HUNTINGTON BEACH,  CA  92649
Applicant Contact RYAN HEANEY
Correspondent
REGULATORY SPECIALISTS, INC.
3722 AVE. SAUSALITO
IRVINE,  CA  92831
Correspondent Contact ROBYN SCOPIS
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Codes
IPF   NGX  
Date Received02/01/2016
Decision Date 09/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-