NHF — Monitor, Orthotic/Prosthetic Class I
FDA product code NHF covers "Monitor, Orthotic/Prosthetic", a Class I medical device regulated under 21 CFR 890.3025. Submissions are reviewed by the Physical Medicine panel.
Classification Details
- Product Code
- NHF
- Device Class
- Class I
- Regulation Number
- 890.3025
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
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.