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, Hydro-Massage
510(k) Number K930821
Device Name THERA-FIT
Applicant
Aquatherapy Systems, Inc.
462 Germantown Pike
Lafayette Hill,  PA  19444
Applicant Contact CHARLES CARFAGNO
Correspondent
Aquatherapy Systems, Inc.
462 Germantown Pike
Lafayette Hill,  PA  19444
Correspondent Contact CHARLES CARFAGNO
Regulation Number890.5100
Classification Product Code
ILJ  
Subsequent Product Code
BXB  
Date Received02/17/1993
Decision Date 11/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Physical Medicine
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-