Hill Holder, Wheelchair

Device Code: 5107

Product Code(s): INA

Device Classification Information

Device Type ID5107
Device NameHill Holder, Wheelchair
Regulation DescriptionWheelchair Component.
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 Number890.3920 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeINA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5107
DeviceHill Holder, Wheelchair
Product CodeINA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionWheelchair Component.
CFR Regulation Number890.3920 [🔎]
TPLC Last Update: 2019-04-02 21:00:20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.