NHF · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.3025
Classification
FDA Product Code
NHF
Device class
Class I — Low Risk (general controls)
Regulation
21 CFR 890.3025
Review panel
PM
Medical specialty
Physical Medicine
Submission type
4
GMP exempt
Y
Life sustaining
N
Implant
N
Third-party review
N
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.