Quality, warranty, safe use and the questions distributors most often ask. All statements here are draft wording for review.
Test reports and their scope
RoHS 2.0 (2011/65/EU, (EU) 2015/863) and REACH SVHC screening were carried out by EMTEK (CNAS-accredited) in March 2026 on polymer material samples. Report numbers: EGZ2603250088C00101R and EGZ2603250088C00201R. A separate coating performance report (TW 241438) concerns a sprayed protective coating material. No claim is made here about certification of the finished prosthetic device.
Warranty
Socket body: 1 year. Cooling electronics: 6 months. The product is individually made and is not returnable for reasons other than quality defects. Warranty terms must be confirmed in the final distribution agreement.
Safe-use notes for your fitting partners
- Fitting and adjustment must be performed by a qualified prosthetist or clinician.
- The device is made for one individual only and must not be lent to another person.
- Do not use when the residual limb has wounds, ulcers, redness or infection.
- The electronic cooling unit must not be immersed in water or exposed to rain.
Distributor FAQ
Is this a stock item or made to order?
It is individually made from 3D scan data of the residual limb. There is no universal size.
Who performs the fitting?
A qualified prosthetist or clinician. The supplier does not fit end users directly.
Does the device contain a battery?
No built-in large battery. It is powered externally over USB-C 5 V / 9 V.
Are CE MDR or ISO 13485 certificates available?
Not supplied for this draft. Do not state that they exist until verified certificates are provided.
What about MOQ and lead time?
To be confirmed by the client before launch. No figure is published on this draft.
Medical and regulatory notice
Nothing on this site is a medical claim, a guarantee of therapeutic outcome, or a certification of the finished device. The product must be fitted and adjusted by qualified professionals and is intended only for the individual for whom it was made. Material test reports cover the tested material only. Final legal wording, market-specific approvals and privacy information are the responsibility of the operator.