Rehabilitation equipment for North American importers and distributors
North American buyers rarely ask about price first. They ask for the FDA registration number, the label artwork, and whether the product is a Class I exempt device — because those three things decide whether the container clears customs and whether Amazon will accept the listing.
This page lays out what the manufacturer provides, what your importer of record has to file, and where the two usually get confused.
How these products are classified
Most walking aids, canes, walkers, rollators, commode chairs, shower chairs and toilet safety rails are regulated by the FDA as Class I devices and are 510(k)-exempt. Exemption from premarket notification is not exemption from regulation: the establishment must register and each device must be listed. Some products carrying therapeutic claims, or supplied sterile, fall outside the exemption and need a 510(k) — check the classification database for your exact product code before you assume.
This is general guidance based on how these product types are normally regulated. Final classification for your exact product and claims is decided by your regulatory advisor or the authority.
Documents required, and who files each one
Most first-order delays come from a document nobody realised was the importer’s responsibility. This is the split.
| Document | Responsibility | Notes |
|---|---|---|
| Establishment registration (FDA) | We provide | Filed annually by the manufacturing establishment; the registration number is what your broker will ask for. |
| Device listing | We provide | One listing per device/listing combination. Registration without listing is a common gap in competitor paperwork. |
| Declaration of Conformity | We provide | States the classification, the applicable regulation and that the device meets it. |
| Label artwork to 21 CFR 801 | Shared | Manufacturer supplies artwork; the importer’s name and address must appear if you are the importer of record. |
| UDI / GUDID entry | You / your local entity | Class I devices require UDI labelling. The GUDID record is normally created by the labeler — often you, not us. |
| Import entry (CBP Form 7501) | You / your local entity | Your customs broker files this; we supply the commercial invoice, packing list and HS code. |
How the goods get there
What usually goes wrong
- Treating the FDA registration number as an approval — it is not, and Amazon and CBP treat the two differently.
- Using a label that names the Chinese manufacturer as the importer of record.
- Assuming 510(k) exemption covers a product once a therapeutic claim is added to the packaging.
Categories that move in this market
North America buyer questions
Do you have an FDA registration number we can verify?
Is a shower chair a medical device in the US?
Can you ship directly to an Amazon FBA warehouse?
What HS code applies to walking aids and shower chairs?
Other markets
Shipping to North America?
Send the product and destination. We reply in 24 hours with the document list for your market, the responsible party for each item, and an itemised FOB quote.