FDA-Registered FacilityUS Agent on FileISO 13485 Amazon US: 4.9★MOQ 50/SKUDDP Door Delivery

Factory or Trader? Seven Questions That Tell You Which

A practical vetting guide for mobility aid buyers · Updated 2026-10-22

Most suppliers look identical on a website. These seven questions separate them.

1. “What is the FDA product code for this model?”

A manufacturer knows. A trader asks someone else and gets back to you in two days. For walkers the answer is IOR, for rollators ITZ — both 510(k) exempt under 21 CFR 880.5500. We cover the detail in our 510(k) guide.

2. “What is the carton dimension and how many units fit in a 40HQ?”

These numbers decide your landed cost. Anyone who cannot produce them immediately is not shipping from a factory they control. Our DDP door-delivery terms are priced on exactly these figures.

3. “What is different about your bariatric frame?”

A real answer mentions tube thickness, weld specification, frame geometry or seat construction. A weak answer repeats the load number.

4. “Send me the load-test report for this model.”

A test report has a date, a method and a result. If what comes back is a photo of a certificate frame, you have your answer.

5. “What is the name and address on your business licence?”

Then check that the same name appears on the FDA registration, the trademark record and the product label. A supplier whose legal name changes depending on which document you look at is a supplier with a problem you will inherit.

6. “Can I send an inspector before the container loads?”

A manufacturer says yes without hesitation. A trader has to check with someone, because they are not the one being inspected. We welcome SGS, BV or TÜV and will hold the loading date for your inspector — see what happens inside the factory.

7. “What is your MOQ for private label?”

This one is not about legitimacy — it is about who they are set up to serve. A 300-unit minimum means large established brands. A lower minimum means they are organised to work with growing dealers. Our answer: 50 units per SKU — here is how the private label programme works.

The pattern behind the seven

Every legitimate answer is specific, immediate and checkable. Every evasion follows the same shape: a promise, a delay, and a reason why the document cannot be shared right now.

Where we stand on each

QuestionOur answer
Product codeWalkers IOR, rollators ITZ, others confirmed per device
Carton and loadingSupplied per model on request
Bariatric differenceStated per model
Load test reportAvailable
Legal entityOne unified legal entity across registration, trademark and product label
Third-party inspectionYes — SGS, BV or TÜV, and we will hold the loading date
Private label MOQ50 units per SKU

For the honest trade-offs of buying direct instead of through a big-brand channel, read our brand vs private label comparison.

Ask Us the Seven Questions

Note. This page is a vetting framework for B2B equipment buyers, not a legal or compliance opinion. Always verify supplier claims against primary documents: business licence, FDA registration, test reports and your own inspection visit.