# Monitor, Orthotic/Prosthetic
> **Product code: NHF** · Class I — Low Risk (general controls) · Physical Medicine · 21 CFR 890.3025
## Classification
- **FDA Product Code:** NHF
- **Device class:** Class I — Low Risk (general controls)
- **Regulation:** 21 CFR 890.3025
- **Review panel:** PM
- **Medical specialty:** Physical Medicine
- **Submission type:** 4
- **GMP exempt:** Y
- **Life sustaining:** N
- **Implant:** N
- **Third-party review:** N
## 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.

## Market data
- **Cleared 510(k) submissions:** 0
- **Registered establishments:** 11
## Source
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=NHF)
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