Table, Mechanical

Device Code: 5121

Product Code(s): INW

Device Classification Information

Device Type ID5121
Device NameTable, Mechanical
Regulation DescriptionMechanical Table.
Regulation Medical SpecialtyPhysical Medicine
Review PanelPhysical Medicine
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Physical Medicine And Rehabilitation Devices Branch (PMDB)
Submission Type510(K) Exempt
CFR Regulation Number890.3750 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeINW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5121
DeviceTable, Mechanical
Product CodeINW
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionMechanical Table.
CFR Regulation Number890.3750 [🔎]
Device Problems
Improper Or Incorrect Procedure Or Method
1
Adverse Event Without Identified Device Or Use Problem
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 21:00:36

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