Board, Scooter, Prone

Device Code: 5206

Product Code(s): KNL

Device Classification Information

Device Type ID5206
Device NameBoard, Scooter, Prone
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 CodeKNL
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5206
DeviceBoard, Scooter, Prone
Product CodeKNL
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionNonmeasuring Exercise Equipment.
CFR Regulation Number890.5370 [🔎]
TPLC Last Update: 2019-04-02 21:02:07

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