NHF

Monitor, Orthotic/Prosthetic

Product code

NHF

Device name

Monitor, Orthotic/Prosthetic

Device class

Class 1

21 CFR

21 CFR 890.3025

Medical specialty

Physical Medicine

Marketing pathway

510(K) Exempt

Flag

GMP exempt

FDA classification 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).