Chair, Geriatric

Device Code: 2599

Product Code(s): FRJ

Device Classification Information

Device Type ID2599
Device NameChair, Geriatric
Regulation DescriptionMedical Chair And Table.
Regulation Medical SpecialtyGeneral Hospital
Review PanelGeneral Hospital
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
General Hospital Devices Branch (GHDB)
Submission Type510(K) Exempt
CFR Regulation Number880.6140 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeFRJ
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2599
DeviceChair, Geriatric
Product CodeFRJ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMedical Chair And Table.
CFR Regulation Number880.6140 [🔎]
Device Problems
Unstable
2
Adverse Event Without Identified Device Or Use Problem
2
Use Of Device Problem
1
Device Tipped Over
1
Improper Or Incorrect Procedure Or Method
1
Device Sensing Problem
1
Failure To Sense
1
Device Alarm System
1
Break
1
Total Device Problems 11
Recalls
Manufacturer Recall Class Date Posted
1
Hill-Rom, Inc.
II Feb-23-2016
TPLC Last Update: 2019-04-02 20:15:46

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