Compliance & Manufacturing Standards
Compliance & Manufacturing Standards
Siweeci powered wheelchairs, stair climbers, and mobility scooters are designed and manufactured through supply partners whose facilities operate under internationally recognized quality and safety systems. We build compliance verification into supplier qualification and production oversight — so the products we ship meet the regulatory baselines your market requires.
Detailed certificates, audit reports, and per-model scope statements are provided to verified business partners during onboarding, under NDA. We don't publish certificate numbers or facility identities publicly — but we'll share the full package the moment a distribution agreement is in discussion.
What our products are built to
| Standard | What it means for your market |
|---|---|
| ISO 13485 | Manufactured in a medical-device quality-management-certified facility — the discipline behind consistent build quality. |
| US FDA framework | Powered mobility placed on the US market through applicable FDA clearance pathways for Class II devices. |
| CE / EU MDR 2017/745 | Products conform to the European Medical Device Regulation for the EU market. |
| UN38.3 | Lithium battery systems tested for safe air and ground transport — what makes them shippable and airline-compliant. |
UN38.3 — why it matters for shipping
Every lithium-battery product is tested to UN 38.3, the requirement for transport of lithium cells. This is what makes our battery packs shippable and airline-compliant. For the 300 Wh airline threshold and what it means for your customers, see 300 Wh: The Number That Decides Whether Your Customer Can Board the Plane.
Getting the documents for your market
Regulatory requirements differ by country, and the exact certificate, notified-body, and product-code details your registration needs are best handled one-to-one. Tell us your target markets and we'll assemble the evidence file for those specific approvals.
Before you list: confirm coverage for your target market with our team — we verify per model.
Full package: certificates, test reports, and scope statements are released to verified distributors under NDA during onboarding.
Start here: Contact our team · OEM, battery upgrades & customization · Browse the powered wheelchair range.