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

Walkers & Rollators — Wholesale, Private Label, DDP

Folding walkers, wheeled walkers and rollators with seats. 510(k)-exempt product codes IOR and ITZ. Private label from 50 units per SKU.

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This is the one line in our range where the US regulatory position is unambiguous and worth stating plainly: standard non-wheeled walkers fall under FDA product code IOR, and wheeled walkers and rollators under ITZ — both 510(k) exempt. No premarket submission is required. For a dealer, that means no regulatory delay between your purchase order and your shelf.

Why dealers take this line

Products in This Line (11 SKUs, Ready Stock)

Every unit below ships with your logo from 50 units per SKU. Click any product to request wholesale pricing.

Models in this line

ModelTypeFrameNotes
LM2002-SWalker with seatStainless steelMedical, foldable
LM2002-S-W1Rollator, 2-wheelStainless steelLightweight, black
LM2002-S-W1-FSWheeled walker with seatStainless steelFolding
LM2001-S-W1-FSDual front-wheel walkerStainless steelFolding walking aid
LM2001-SFolding walkerStainless steelMatte black
YC8230Dual front-wheel walkerSteel—
YC8301Dual-wheeled walkerAluminiumRehab use
LM2005L-S / LM2005TPaediatric walkerStainless steelChild sizes

Private Label

Logo on frame, carton and manual. From 50 units per SKU.

Regulatory

UNIONCARE operates an ISO 13485 quality system and maintains FDA establishment registration with a US Agent on file. Walkers (IOR) and rollators (ITZ) are 510(k) exempt under 21 CFR 880.5500.

Common Questions

Are walkers FDA-approved?

Walkers (IOR) and rollators (ITZ) are 510(k) exempt — no premarket submission required, and our facility is FDA-registered.

Do you offer paediatric sizes?

Yes — paediatric walkers ship in the same container as adult models.

Do you ship DDP?

Yes — one landed cost, delivered to your US door in 5–6 weeks.

One Landed Cost. Delivered to Your Door.

We ship DDP. Ocean freight, export clearance, US import clearance, duty and final delivery are all on our invoice — one landed cost, quoted before you commit, and it does not move afterwards. 5–6 weeks from order to your dock. Core SKUs ship from ready stock, with no production lead time.

Request Wholesale Pricing

Send your model list, target volumes and destination port. Wholesale quote within 24 hours. Private label welcome from 50 units per SKU. Single sample units available before any bulk commitment.

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