How to Import Mobility Aids into the US — FDA and Customs
A practical checklist for a first order, in the order the questions actually come up.
1. Is the product a medical device, and who is responsible for what?
Mobility aids are regulated as medical devices in the US. The manufacturer carries the registration and listing obligations; the importer is identified at entry. These are different roles held by different parties, and a supply contract should say who is which — in writing.
2. Is a 510(k) required?
For standard walkers (product code IOR) and rollators (ITZ): no, they are 510(k) exempt under 21 CFR 880.5500 — see our page on walker product codes IOR and ITZ for what exemption still requires. For other categories, check the product code for the specific device. A supplier who cannot tell you the product code is a supplier who has not done the work.
3. What has to be on the label?
The manufacturer's name and address, the device description, the load rating where applicable, and — for an imported device — the importer's identification. Instructions for use in English. A private-label programme changes whose logo appears; it does not remove the manufacturer's legal identity from the label.
4. What does the landed cost actually include?
FOB quotes leave freight, duty and brokerage with you, and those numbers move. DDP puts all of it on one invoice, quoted before you commit. For a dealer planning a season, the second is easier to price into a retail plan. Our DDP door-delivery programme lands containers in 5–6 weeks with duties and brokerage included in one invoice.
5. What should the supplier have ready before the first purchase order?
- Establishment registration and device listing details
- ISO 13485 certificate
- Product code (and 510(k) status)
- Test reports for load ratings you intend to advertise
- US Agent details
Read this section the way a buyer would
Everything on this list is cheap for a supplier to provide and expensive for you to discover later. A supplier that answers all five without stalling is a supplier worth keeping. Ours are on the compliance page, and the commercial terms behind them — MOQ 50 units per SKU, 13 years of export history — are on the wholesale terms page.
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Notes and disclaimer. FDA registration, device listing, product codes and customs procedures change over time; this page reflects the regulatory framework as verified on 2026-10-09. Always confirm current requirements with the FDA, CBP and your customs broker before shipping. This page is written for equipment buyers and does not constitute regulatory, legal or customs-brokerage advice.