Monitor, Orthotic/Prosthetic
The Monitor, Orthotic/Prosthetic (product code NHF) is a non-invasive, battery-powered, data storage device used to monitor the function and usage of orthotic or prosthetic devices worn by patients, as described in its definition. It is classified as an FDA Class 1 device within the Physical Medicine specialty, the lowest risk category, subject to general controls and exempt from 510(k) premarket notification. No specific regulation number has been assigned to this product code. The device is not flagged as an implant or life-sustaining device.
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Basic Information
- Product Code
- NHF
- Device Class
- FDA class 1
- Regulation Number
- 890.3025
- Medical Specialty
- Physical Medicine
- Review Panel
- PM
- Submission Type
- 4
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 11 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 11 registration numbers. Click on an entry to view related FDA registrations.