• 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 patient bed with canopy/restraints
Regulation Description Protective restraint.
Definition Enclosed bed canopy system used as passive restraint.
Product CodeOYS
Regulation Number 880.6760
Device Class 1


Premarket Reviews
ManufacturerDecision
J. T. POSEY CO.
  SUBSTANTIALLY EQUIVALENT 3

Device Problems
Detachment of device component 10
No code available 9
Component missing 4
Use of Device Issue 4
Unknown (for use when the device problem is not known) 2
Break 2
Defective component 2
Device damaged prior to use 1
Other (for use when an appropriate device code cannot be identified) 1
Instruction for use issue 1
Material separation 1
Torn material 1
Total Device Problems 38

-
-