The consent decree limits Invacare’s ability to sell certain custom manual and power wheelchairs, wheelchair components and subassemblies manufactured at Invacare’s Taylor Street facility in Elyria, Ohio. These restricted products are listed in the Notification Guide, as are the exceptions under which Invacare is permitted to manufacture and sell these devices.
Verification of Medical Necessity Forms
To prevent disruption to patients, the FDA will allow Invacare to continue manufacturing and distributing wheelchairs and seating systems with the completion of a Verification of Medical Necessity form. This document contains two different forms:
- The first is for replacement devices for when a patient needs to replace his or her current Invacare wheelchair and/or seating system, or if that wheelchair or seating system has been discontinued or, if the patient's needs have changed, a substantially similar product
- The second is for new users, when in the professional judgment of a clinician, an Invacare wheelchair or seating system is necessary to meet the medical needs of a patient, due to a specific aspect of the patient's condition that could not be appropriately met by another manufacturer's device.
- Verification of Medical Necessity Form - Replacement >
- Verification of Medical Necessity Form - New Consumer >
- Verification of Medical Necessity Interactive Form - Replacement/New Consumer >
Service Parts and Warranty Replacement Forms
The FDA will allow Invacare to continue manufacturing service parts and replacements for Taylor Street devices. To receive components, parts, raw materials, accessories or sub-assemblies to service or repair Taylor Street devices, please complete the Service Parts form. You will need to complete this form only once during the time that Invacare is under the consent decree for all service parts.
If you need a warranty replacement of a wheelchair or seating system, please complete the Warranty Replacement form.
Purchase Orders and Quotes Form
The FDA recognizes that some patients for whom providers had ordered or had received a written quote for a Taylor Street device prior to the date of entry of the consent decree would be adversely affected by a delay in order fulfillment. To have your purchase order or quote fulfilled, please complete the Purchase Orders and Quotes form stating your intent to have your order filled and shipped.