_______ 9. All devices are custom-made and cannot be returned or refunded. This is non-negotiable. Once ordered, you are responsible for the full payment, regardless of treatment outcomes. For cranial remolding helmets, the FDA mandates a 14-day timeframe from ordering to fitting: if an appointment is canceled, rescheduled, or missed, causing the delivery to exceed the 14-day window, the patient may be responsible for the device cost, even if the device is not delivered.