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 Bath, Sitz, Powered
510(k) Number K953796
Device Name BANKS HYDRO-THERAPY CHAIR
Applicant
Keith Products, Inc.
952 Airport Rd.
Shelby,  NC  28150
Applicant Contact DAVID S BANKS JR.
Correspondent
Keith Products, Inc.
952 Airport Rd.
Shelby,  NC  28150
Correspondent Contact DAVID S BANKS JR.
Regulation Number890.5100
Classification Product Code
ILM  
Date Received08/14/1995
Decision Date 04/01/1996
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
Predetermined Change
Control Plan Authorized		 No
-
-