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 stationary ultrasonic diathermy device for use in applying therapeutic deep heat
510(k) Number K072256
Device Name HF54 COMBINATION ULTRASOUND INTERFERENTIAL AND PREMODULATED STIMULATION SYSTEM WITH OPTIONAL HANDS-FREE OPERATION, MODEL
Applicant
HILL LABORATORIES CO.
3 N. BACTON HILL RD.
FRAZER,  PA  19355
Applicant Contact BRADY ALLER
Correspondent
HILL LABORATORIES CO.
3 N. BACTON HILL RD.
FRAZER,  PA  19355
Correspondent Contact BRADY ALLER
Regulation Number890.5300
Classification Product Code
PFW  
Subsequent Product Codes
ILY   LIH  
Date Received08/13/2007
Decision Date 03/12/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-