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

Frequently Asked Questions

The questions US dealers ask us first, answered plainly. If yours is not here, send it directly — you will get a straight answer within 24 hours.

Ordering and MOQ

What is your minimum order?
50 units per SKU for private label. Sample orders start at one unit.
Can I mix SKUs in one container?
Yes. Mixed-SKU containers are how most of our dealers start. See wholesale terms for how pricing works across a mixed load.

Private label

Can I put my own logo on the product?
Yes, from 50 units per SKU. Your logo goes on the product, retail carton, user manual and master carton. Details in the private label programme.
Whose name goes on the label?
Ours, as manufacturer, in addition to yours. That is a legal requirement for a medical device, and it is what keeps your brand from taking on manufacturer obligations.
Do I choose the model numbers?
Yes. So does the barcode and the carton artwork.
Is there territory exclusivity?
No — not at this stage. We would rather say that plainly than promise something we cannot enforce.

Shipping and cost

Do you ship DDP?
Yes. Ocean freight, US customs clearance, duty and delivery are all on one invoice. 5–6 weeks door to door. See DDP shipping.
Will the landed cost change after you quote?
No. That is the point of quoting DDP.
Do you have stock in the US?
No. Stock is held in China; core SKUs ship with no production lead time.

Compliance

Are you FDA registered?
Yes — FDA establishment registration with a US Agent on file. Full detail on the certifications page.
Do your products need a 510(k)?
Walkers (product code IOR) and rollators (ITZ) are 510(k) exempt under 21 CFR 880.5500. Other categories are confirmed per device.
Can you say “FDA approved”?
No, and neither should any supplier. FDA does not approve devices in that sense. The accurate terms are registered and exempt.

Samples and quality

Can I order one unit first?
Yes.
Will you film my order before it ships?
Yes. Ask, and we will. More on how we control quality in the factory and quality page.
Can I send an inspector?
Yes. SGS, BV or TÜV on site before loading — we will accommodate the schedule.

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