Monitor, Orthotic/prosthetic

Device Code: 5227

Product Code(s): NHF

Definition: A Monitor, Orthotic/prosthetic Is A Non-invasive, Battery-powered, Data Storage Accessory Device That Is Attached To Or Embedded In Medical Appliances Such As Splints, Braces, Orthotics, Prosthetics, And Wearable Exercise Devices, To Record How Often

Device Classification Information

Device Type ID5227
Device NameMonitor, Orthotic/prosthetic
Regulation DescriptionProsthetic And Orthotic Accessory.
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 Number890.3025 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeNHF
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5227
DeviceMonitor, Orthotic/prosthetic
Product CodeNHF
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionProsthetic And Orthotic Accessory.
CFR Regulation Number890.3025 [🔎]
TPLC Last Update: 2019-04-02 21:02:27

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