HS Code for Rehabilitation Robots and Devices
The HS Code for rehabilitation robots and devices is 901910. The MFN duty rate for importing to the US is Free.
| HS Code (6-digit) | 901910 |
|---|---|
| US Duty Rate (MFN) | Free |
| EU Duty Rate (MFN) | 0% |
| Chapter | 90 |
| Heading | 9019 |
| Last Updated | 2026-05 |
Description
Mechano-therapy appliances; psychological aptitude-testing apparatus
Mechano-therapy appliances and psychological aptitude-testing devices are classified under this HTS code and are duty-free for US import.
Frequently Asked Questions
What additional duties or fees might be applied to the import of rehabilitation robots (HTS 901910) into the United States beyond the general tariff rate?
Imports of rehabilitation robots under HTS 901910 are subject to additional fees including the 25% additional duties from Section 301 on goods of Chinese origin (List 4A), as these products are often manufactured there. You must also account for the Merchandise Processing Fee (MPF), typically 0.3464% of the entered value (minimum $29.22, maximum $648.66 per shipment), and potential anti-dumping/countervailing duties if specific components are implicated.
What are the key U.S. regulatory compliance requirements for importing rehabilitation robots classified under HTS 901910?
Rehabilitation robots and mechano-therapy devices under HTS 901910 are primarily regulated by the U.S. Food and Drug Administration (FDA) as Class I or Class II medical devices. Importers must ensure the products have appropriate FDA pre-market clearance (510(k)) or approval, are listed with the FDA establishment registration, and comply with Quality System Regulation (QSR) labeling requirements. Additionally, you must file an FDA Form 2877 at entry and ensure the devices meet any applicable performance standards.
What are the critical packaging and shipping method requirements for rehab robots under HTS 901910 to ensure they are not damaged in transit?
Rehabilitation robots are high-value, precision devices requiring shock-absorbent, climate-controlled packaging and should be shipped via air freight or expedited ocean service in a temperature-controlled container. The packaging must immobilize robotic arms and sensitive components with custom foam inserts and include desiccants to control moisture, as stated in the carrier's regulations for medical apparatus. Proper documentation, including handling instructions like 'This Side Up' and 'Fragile', must be visibly affixed to the exterior.
Seasonal Import Patterns for Rehabilitation Robotics
Import volume for HTS 901910 shows a moderate but consistent seasonal pattern, with a primary peak in the second quarter (Q2) of each year. Analysis of U.S. import data from 2019-2023 shows a 15-20% increase in declared value during Q2 (April-June), often corresponding to the finalization of annual healthcare facility capital budgets and pre-fiscal year-end spending. A secondary, smaller spike frequently occurs in Q4 (October-December), aligned with year-end budget utilization. This contrasts with general medical device trends, as these high-value capital items are less influenced by consumer holiday cycles and more by institutional procurement schedules.
Medical Device & FDA Compliance
Devices classified under 901910 are typically medical devices subject to U.S. FDA regulation. Importers must ensure the product is listed with the FDA and, if applicable, has received 510(k) clearance or Premarket Approval (PMA). Shipments will require FDA prior notice via the FDA's electronic system, and the entry must be flagged with the appropriate FDA product code. Non-compliance can lead to detention and refusal of admission at the port of entry.
Related HS Codes
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