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 K070766
Device Name PSI BANDS
Applicant
PSI HEALTH SOLUTIONS, INC.
606 LIGHTHOUSE AVE. #168
PACIFIC GROVE,  CA  93950
Applicant Contact ROMY TAORMINA
Correspondent
PSI HEALTH SOLUTIONS, INC.
606 LIGHTHOUSE AVE. #168
PACIFIC GROVE,  CA  93950
Correspondent Contact ROMY TAORMINA
Classification Product Code
MVV  
Date Received03/20/2007
Decision Date 07/26/2007
Decision Substantially Equivalent (SESE)
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-