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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