A company is eligible for participation in the ORI Seal of Approval Program if it satisfies the following criteria:

• It is the primary manufacturer or producer of the product.
  
  
• The product is a specific individual device that is manufactured according to established production specifications. The Seal of Approval is not granted to custom, one of a kind products or to a class or group of products even if they have some features in common.
  
  
• The product is not a medical device or system that is legally required to have an FDA or other federal or state government clearance or certification (i.e. must not be subject to 510K or IDE requirements).
  
  
• The product is a device that requires manipulation by the musculoskeletal system or that significantly influences the performance, health or fitness of the musculoskeletal system.
  
• The product is not operated by electricity unless it has received the Underwriters Laboratory Seal of Approval before submission to the Orthopaedic Research Institute.