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 Exerciser, Powered
510(k) Number K873658
Device Name ANKLE REFLEX TREATMENT UNIT (ARTU)
Applicant
Universal Gym Equipment, Inc.
C/O Darby & Darby
405 Lexington Ave.
New York,  NY  10174
Applicant Contact GORDON D COPLEIN
Correspondent
Universal Gym Equipment, Inc.
C/O Darby & Darby
405 Lexington Ave.
New York,  NY  10174
Correspondent Contact GORDON D COPLEIN
Regulation Number890.5380
Classification Product Code
BXB  
Date Received09/10/1987
Decision Date 04/21/1988
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
-
-