Reclassify Pediatric Mobility Devices/Wheelchairs (DME) from a Class I Medical Device to a Class II Medical Device.

Sophia's Gift: To bring safety standards and regulation to equipment used by handicapped children here in the United States. Children's products such as strollers have standards in place to keep our children safe. This is not the case for our special needs children. Pediatric Mobility Devices / Wheelchairs are classified as Class I Medical Devices by the FDA (as are bandages and examination gloves), subject only to General Controls. We want to reclassify Pediatric Durable Medical Equipment to a Class II Medical Device. In addition to General Controls, they will require Special Controls. Special controls are device-specific and include : Performance standards, post market surveillance, patient registries, special labeling requirements, premarket data requirements, and guidelines.