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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device monitor, orthotic/prosthetic
Regulation Description Prosthetic and orthotic accessory.
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 CodeNHF
Regulation Number 890.3025
Device Class 1