HS Code for Orthopedic Braces and Supports
The HS Code for orthopedic braces and supports is 902119. The MFN duty rate for importing to the US is Free.
| HS Code (6-digit) | 902119 |
|---|---|
| US Duty Rate (MFN) | Free |
| EU Duty Rate (MFN) | 0% |
| Chapter | 90 |
| Heading | 9021 |
| Last Updated | 2026-05 |
Description
Other orthopaedic appliances
HTS 902119 covers orthopedic braces and supports not otherwise specified, and these imports are duty-free in the United States.
Frequently Asked Questions
What are the primary cost factors beyond the product price when importing orthopedic braces under HTS 902119?
The key additional costs are a 2.7% Most-Favored-Nation (MFN) tariff duty, a Merchandise Processing Fee (MPF) of 0.3464% of the entered value (minimum $29.22, maximum $648.65), and a potential FDA user fee for medical device registration. For goods valued over $800, you must also factor in customs brokerage fees, which vary by provider.
What regulatory approvals are required to import orthopedic braces (HTS 902119) into the United States?
The U.S. Food and Drug Administration (FDA) regulates orthopedic braces and supports as Class I or Class II medical devices, requiring either premarket notification [510(k)] or exemption. The importer of record must provide the FDA entry number and ensure the product listing and establishment registration are in order prior to customs clearance. Shipments lacking proper FDA documentation will be detained by U.S. Customs and Border Protection.
What special packaging or labeling is required when shipping orthopedic braces and supports under HTS 902119?
Orthopedic braces and supports must be packaged to prevent damage and contamination during transit, as they are considered medical devices. Shipments often require clear labeling such as 'Medical Device' and may need to include documentation like a commercial invoice with the HTS code and a certificate of origin for customs clearance.
Seasonal Import Trends for Orthopedic Braces & Supports
U.S. imports of orthopedic and fracture appliances under HTS 902119 show a consistent seasonal pattern, with a significant peak in the third quarter (July-September). Import value in Q3 is typically 15-25% higher than the annual quarterly average, driven by increased activity in summer sports and outdoor recreation leading to more injuries. This trend is most pronounced for knee and ankle braces. Data from the U.S. International Trade Commission shows this Q3 surge is reliable year-over-year, making it a key planning period for distributors and retailers.
Compliance Notes: FDA & Medical Device Requirements
Orthopedic braces and supports classified under 9021.19 are regulated as medical devices by the U.S. FDA. Simple, non-sterile elastic supports may be subject to FDA regulations under 21 CFR Part 801 and 21 CFR Part 807, while more complex braces (e.g., knee braces intended for osteoarthritis) may require 510(k) premarket notification. Importers must ensure their products comply with FDA registration, listing, and labeling requirements, including the device's intended use. Shipments lacking proper FDA documentation or bearing unauthorized medical claims are subject to detention by U.S. Customs and Border Protection (CBP).
Related HS Codes
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