Bars, Parallel, Exercise

Device Code: 5127

Product Code(s): IOE

Device Classification Information

Device Type ID5127
Device NameBars, Parallel, Exercise
Regulation DescriptionNonmeasuring Exercise Equipment.
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 Number890.5370 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIOE
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5127
DeviceBars, Parallel, Exercise
Product CodeIOE
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNonmeasuring Exercise Equipment.
CFR Regulation Number890.5370 [🔎]
Device Problems
Patient Device Interaction Problem
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 21:00:42

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