• 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, non-measuring
Regulation Description Nonmeasuring exercise equipment.
Product CodeION
Regulation Number 890.5370
Device Class 1


Premarket Reviews
ManufacturerDecision
INNOVATIVE PRODUCTS UNLIMITED, INC.
  SUBSTANTIALLY EQUIVALENT 1

Device Problems
Material integrity issue 4
Use of Device Issue 3
No code available 2
Product quality issue 2
Material rupture 1
Slippage of device or device component 1
No Known Device Problem 1
Total Device Problems 14

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 1 0 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Amtryke LLC II Apr-24-2015
2 North Coast Medical Inc II May-14-2012

-
-