Product code NHF

Device name
Monitor, Orthotic/Prosthetic
Medical specialty
Physical Medicine
Device class
1
Regulation number
890.3025
Review panel
PM
Implant
N
Life sustaining/supporting
N
GMP exempt
Y
Third party review
N
Summary malfunction reporting
Eligible
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 the appliance is worn, through the use of sensors that record changes in temperature, motion, skin proximity, etc.
Source
FDA openFDA device classification dataset