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 Device, Acupressure
510(k) Number K041877
Device Name ACU-STRAP MOTION SICKNESS BAND
Applicant
HEALTH ENT., INC.
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Applicant Contact DANIEL J DILLON
Correspondent
HEALTH ENT., INC.
49 PLAIN STREET
NORTH ATTLEBORO,  MA  02760
Correspondent Contact DANIEL J DILLON
Classification Product Code
MVV  
Date Received07/12/2004
Decision Date 10/08/2004
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-