FDA product code NHF: Monitor, Orthotic/Prosthetic

NHF is the FDA product code for monitor, orthotic/prosthetic. It is a Class I device, regulated under 21 CFR 890.3025 and reviewed by the Physical Medicine panel. Devices under NHF reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.

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.

Classification

Recalls for NHF devices

openFDA lists no recalls for product code NHF.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

• L9900 — Orthotic and prosthetic supply, accessory, and/or service component of another hcpcs "l" code

Frequently asked questions

What is FDA product code NHF?

NHF is the FDA product code for monitor, orthotic/prosthetic. It is a Class I device, regulated under 21 CFR 890.3025 and reviewed by the Physical Medicine panel.

What device class is NHF?

Class I, regulation 21 CFR 890.3025. Typical premarket route: 510(k) exempt.

Next steps

• Run an FDA pathway report with predicate devices for product code NHF
• Run a recall and safety report across every NHF manufacturer
• Watch product code NHF for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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