Mobility
What we hold, and what we do not.
Most supplier pages show six logos and no document numbers. This page does the opposite: every document we hold is named, the model it covers is listed, and the gaps are left visible.
Certification is per model.
A CE mark on one chair does not clear the next one. Use this grid before you commit a US or EU listing.
| Model | Type | CE | FDA | UKCA | SFDA | CN Reg. |
|---|---|---|---|---|---|---|
| JYW001 | Wheelchair | ✓ held | ✓ held | ✓ held | ✓ held | ✓ held |
| JYW002 | Wheelchair | ✓ held | in progress | — | — | ✓ held |
| JYW5903 | Wheelchair | ✓ held | ✓ held | ✓ held | — | — |
| JYW5919 | Wheelchair | ✓ held | in progress | — | — | — |
| T100 | Wheelchair | ✓ held | in progress | — | — | — |
| JYZ300 | Walker | ✓ held | ✓ held | — | ✓ held | — |
The documents, named.
Numbered so you can ask for a specific one by reference instead of “your certificates”.
CE — EMC Directive 2014/30/EU
Verification of conformity for the electric wheelchair series, TÜV Thüringen, No. C.21.2109.0180, issued 18 Dec 2021. Covers electromagnetic compatibility; a copy names the models within scope.
Scan on requestCE — declaration of conformity, by model
The declaration that covers the model you are buying, naming the directive it was assessed against. Where an MDR declaration exists for that model, the EU authorised representative is named on it. Both are sent with the quotation — we do not print a CE badge without the document behind it.
Scan on requestU.S. FDA
Documentation held for JYW001, JYW5903 and JYZ300. We state the document type — and the 510(k) number where one applies — when we quote the model, rather than printing a badge here.
Scan on requestUKCA
Conformity documentation for JYW001 and JYW5903 for the UK market.
Scan on requestSFDA
Saudi Food & Drug Authority registration for JYW001 and JYZ300.
Scan on requestCN Reg. (NMPA)
Chinese medical device registration for JYW001 and JYW002.
Scan on requestBattery transport
UN38.3 test summary and MSDS for the lithium pack, issued with the shipping documents so your forwarder can book the battery before the container.
Scan on requestModel test reports
ISO 7176 series reports for stability, braking and static strength — request the report number for the model you are evaluating.
Scan on requestFour questions that separate a mark from a document.
“Which directive, and which models?”
A CE mark can come from the EMC directive, the machinery directive or the medical device regulation. They are not interchangeable, and a certificate that does not name the model does not cover your order.
“Is the FDA document a clearance or a registration?”
An establishment registration is not a 510(k). Ask for the document type and the K-number if there is one — a distributor who repeats “FDA approved” on a listing inherits the problem.
“Which ISO 7176 parts were tested?”
Stability, braking, static strength and obstacle climbing are separate parts of the standard. “Passed ISO 7176” without part numbers means very little.
“Where is the EU authorised representative?”
After MDR, a non-EU manufacturer needs a named EU responsible person on the declaration. If nobody can name one, the paperwork is not finished.
Need the document pack for a tender?
Send the model list and the destination country. We return the document set with the model scope marked on each page — the version your compliance team can file.