Bars, Parallel, Powered

Device Code: 5168

Product Code(s): IRR

Device Classification Information

Device Type ID5168
Device NameBars, Parallel, Powered
Regulation DescriptionPowered 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 Number890.5380 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeIRR
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5168
DeviceBars, Parallel, Powered
Product CodeIRR
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionPowered Exercise Equipment.
CFR Regulation Number890.5380 [🔎]
TPLC Last Update: 2019-04-02 21:01:29

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