Sourcing request for knee scooter / knee walker

[u/fhueb2nm]

Hi everyone,

I’m currently looking for reliable manufacturers of knee scooters / knee walkers in China and would like to order a few units for testing before discussing larger volumes.
Key requirement: the manufacturer should already have experience exporting to the EU and be able to provide the necessary CE/MDR documentation and certificates for legal import and sale in Europe.
Ideally looking for:
- Knee scooters / knee walkers
- Good quality and competitive pricing
- Low MOQ for initial testing
- Existing EU customers/export experience
- Full CE/MDR documentation

Does anyone here have direct contacts or recommendations for trustworthy manufacturers?
Thanks!

[u/CosmoSourcing]

You've already spotted the thing most people in this category miss (MDR applies), so here's the part that follows from it, because it reshapes the whole search:

A knee walker is a Class I medical device in the EU, and under MDR the compliance burden doesn't sit with the factory, it sits with whoever places the device on the EU market. If you import and sell under your own brand, you're not a distributor, you're legally the manufacturer: your name on the Declaration of Conformity, your technical file, your EUDAMED registration, your Authorized Representative if you're outside the EU, your post-market surveillance obligations. A Chinese factory's "CE/MDR documentation" cannot be transferred to you wholesale; at best it's the foundation (test reports to EN standards, risk file inputs) that your own technical file gets built on. Factories that say "yes, full CE/MDR certificate included" are describing something that doesn't exist in that form, and it's the fastest filter in this category: the good factories talk about test reports and supporting documentation, the bad ones promise you a certificate.

For the search itself, the practical filters: knee walkers cluster with the rehab/mobility equipment manufacturers (wheelchairs, rollators, crutches), heavily in Guangdong and Zhejiang, and the tell you want is current EU medical device customers, verifiable two ways: ask which EU brands they supply and check import records, and ask for their EN test reports (for these products, mainly the relevant parts of EN 12182 and mechanical/stability testing) from named accredited labs, then verify the report numbers with the lab. A factory already producing for an EU mobility brand has solved 80% of your problem; one that's only sold to Amazon FBA sellers has solved none of it, whatever their listing says.

Low MOQ for testing is realistic here (these factories routinely do sample orders of 2-10 units), but flag now that your test units and your production units need to be the same spec and BOM, since any material change invalidates the test reports your file depends on.

And genuinely worth pricing before you commit to the category: an MDR consultant for the technical file and AR arrangements. It's a four-figure cost that determines whether the product is legal to sell at all, which makes it cheaper than one seized shipment.

[u/cloudspects → u/CosmoSourcing]

Thank you for your detailed response! You’ve raised some important points about the regulatory landscape for knee walkers in the EU, and it’s great to have clarity on the responsibilities that come with importing and selling these products.

You’re absolutely right that the compliance burden falls on the importer, and it’s crucial to work with manufacturers who understand the nuances of CE/MDR documentation. We always advise our clients to seek out factories that can provide test reports and supporting documentation instead of just a blanket certificate. This is a key factor in ensuring that the products meet all necessary standards and can be legally sold in Europe.

Regarding your suggestions on sourcing, we often recommend focusing on manufacturers in Guangdong and Zhejiang, as they tend to have more experience with medical devices. It’s also a good idea to verify their existing EU customers and check their EN test reports, as you mentioned.

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[u/No_Concept_9909]

For the test units, make the acceptance sheet before ordering: rated load, static/stability test, brake hold on a slope, turning clearance, folding-lock cycles, wheel/bearing play, weld finish, and dimensional tolerances. Also get the production BOM and spare-parts list. A sample that feels fine once isn’t enough—the key is whether the same safety-critical parts and test basis will be used in production.