Market
Selling Assistive Devices into the United States and Canada
US mobility aids are generally regulated as Class I devices. The buyer’s real questions are packaging, weight and documentation.
The United States is the most price-transparent market in the world for mobility aids, and the least forgiving on returns. Products are generally treated as Class I devices, which means establishment registration and device listing rather than premarket approval, plus the documentation an importer or marketplace will request. Two details decide outcomes more often than unit price: packaging that survives a fulfilment centre, and product weight that keeps per-unit fulfilment cost down. Both are design decisions, and both are cheaper to make at the sample stage than after a listing is live.
What buyers in this market ask for
- FDA establishment registration and device listing support
- Marketplace and retail packaging
- Test reports and material declarations
- Weight optimisation for per-unit fulfilment cost
Where the margin actually goes
In a transparent market, the differentiators are the ones a buyer cannot copy from a photo: wall thickness, hinge play, printing durability and the box the product arrives in.
FAQ
Questions buyers ask
Can you supply FBA-ready product?
What documentation is needed for US import?
Other markets
Europe
CE marking, a technical file and a supplier that can answer a compliance question without a week of silence.
Markets →Middle East
Humid coastal climates make corrosion the complaint that ends a distribution agreement. Salt-spray data is the argument that closes it.
Markets →Southeast Asia
Price-sensitive, relationship-driven, and growing fast. Small first orders and fast repeat orders matter more than a low headline price.
Markets →Ordering facts, before you ask
MOQ applies per SKU, not per purchase order — a three-product launch is three minimums. Certificate numbers are published on the certifications page so your importer can verify them with the issuing body.
Get the price list and MOQ sheet
One email. Material options, MOQ by product line and the tooling position — no obligation.