Product code
NHF: Monitor, orthotic/prosthetic
FDA product code · Class I · Physical Medicine
Key facts
| Product code | NHF |
|---|---|
| Device | Monitor, orthotic/prosthetic |
| Device class | Class I |
| Regulation number | 890.3025 |
| Review panel | Physical Medicine |
| Medical specialty | Physical Medicine |
| Submission type | 510(K) Exempt |
| GMP exempt | Yes |
| 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. |
At a glance
- None 510(k) clearances
- None De Novo grants
- None PMA approvals
- None HDE approvals
- 1–9 UDI devices (GUDID)
- None MAUDE adverse event reports
- None Recalled products (Z-numbers)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device product codes
FDA product codes classify medical devices by type and intended use; each code maps to a device class, a classification regulation and a review panel.
Source: U.S. Food and Drug Administration (FDA), Product Classification database