• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • 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 exerciser, measuring
Regulation Description Measuring exercise equipment.
Product CodeISD
Regulation Number 890.5360
Device Class 2


Premarket Reviews
ManufacturerDecision
BALTIMORE THERAPEUTIC EQUIPMENT CO.
  SUBSTANTIALLY EQUIVALENT 1
BATTLE CREEK MANUFACTURERS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CYBEX
  SUBSTANTIALLY EQUIVALENT 1
ERGOLINE GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEDEX
  SUBSTANTIALLY EQUIVALENT 1
TRI W-G, INC.
  SUBSTANTIALLY EQUIVALENT 2

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 2 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 BTE Technologies, Inc. II Jul-06-2015
2 MedX Holdings, Inc. II Jan-07-2015

-
-