Folding walkers, wheeled walkers and rollators with seats. 510(k)-exempt product codes IOR and ITZ. Private label from 50 units per SKU.
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.
Every unit below ships with your logo from 50 units per SKU. Click any product to request wholesale pricing.











| Model | Type | Frame | Notes |
|---|---|---|---|
| LM2002-S | Walker with seat | Stainless steel | Medical, foldable |
| LM2002-S-W1 | Rollator, 2-wheel | Stainless steel | Lightweight, black |
| LM2002-S-W1-FS | Wheeled walker with seat | Stainless steel | Folding |
| LM2001-S-W1-FS | Dual front-wheel walker | Stainless steel | Folding walking aid |
| LM2001-S | Folding walker | Stainless steel | Matte black |
| YC8230 | Dual front-wheel walker | Steel | — |
| YC8301 | Dual-wheeled walker | Aluminium | Rehab use |
| LM2005L-S / LM2005T | Paediatric walker | Stainless steel | Child sizes |
Logo on frame, carton and manual. From 50 units per SKU.
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.
Walkers (IOR) and rollators (ITZ) are 510(k) exempt — no premarket submission required, and our facility is FDA-registered.
Yes — paediatric walkers ship in the same container as adult models.
Yes — one landed cost, delivered to your US door in 5–6 weeks.
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.
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.