Chair, Examination And Treatment

Device Code: 2600

Product Code(s): FRK

Device Classification Information

Device Type ID2600
Device NameChair, Examination And Treatment
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 CodeFRK
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2600
DeviceChair, Examination And Treatment
Product CodeFRK
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMedical Chair And Table.
CFR Regulation Number880.6140 [🔎]
Device Problems
Break
4
Bent
3
Unintended System Motion
2
Device Subassembly
2
Unintended Movement
1
Wheel
1
Detachment Of Device Or Device Component
1
Caster
1
Device Component Or Accessory
1
Total Device Problems 16
TPLC Last Update: 2019-04-02 20:15:47

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