Artificial Body Parts (Not Elsewhere Specified)

The NES (not elsewhere specified) designation means this heading captures articles that do not fit a more specific category. Importers should first evaluate whether the device falls under a heading for orthopedic appliances, artificial joints, hearing aids, or dental fittings. If none of those headings apply, the NES heading is appropriate. For novel devices where classification is genuinely ambiguous, a binding ruling request to CBP is the most reliable path to certainty.

Externally powered upper-limb prostheses are generally regulated as Class II medical devices by FDA, typically requiring 510(k) premarket notification unless a specific exemption applies. The foreign manufacturer must be registered with FDA, and the device must bear compliant labeling. Importers should confirm the device's FDA classification code and authorization status before the first shipment, as powered prosthetics with novel control systems (e.g., myoelectric or neural-interface) may face additional scrutiny.