Device |
monitor, orthotic/prosthetic |
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. |
Product Code | NHF |
Regulation Number |
890.3025
|
Device Class |
1
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