Overview
The EmpowerRide Navigator is a pediatric manual mobility device designed to provide structured seated positioning and caregiver assisted mobility for children with mobility limitations.
The device supports pediatric users who require medical mobility assistance in medical, community, and daily living environments. It was developed to address clinical mobility needs that cannot be safely met by consumer mobility products. The Navigator provides adaptive seating support, postural positioning, caregiver assisted mobility, and a removable seating module that allows flat positioning when clinically indicated. The device is designed for safety, stability, and clinical integrity.
Engineering Excellence
The device was reviewed under the FDA 510(k) premarket notification pathway and determined to be substantially equivalent to legally marketed predicate devices for intended use and safety profile.
Prescription based medical equipment through Durable Medical Equipment (DME) providers.
Subject to payer determination of medical necessity.
The device was evaluated for substantial equivalence to predicate pediatric mobility devices with respect to intended use, performance characteristics, and safety requirements.
Engineering Excellence
The Navigator may be prescribed for pediatric patients with mobility limitations affecting safe ambulation, positioning, or functional mobility.
The Navigator incorporates engineering controls and validation consistent with recognized mobility standards. Testing supports safe operation in clinical and community environments under normal use conditions.
Engineering Excellence
The Navigator is distributed exclusively through qualified Durable Medical Equipment providers. Coverage is subject to individual payer medical necessity determination.
The EmpowerRide Navigator™ is a prescription-based medical mobility device and is not a consumer retail product. Clinical use and coverage decisions are determined by licensed healthcare professionals and payer policies.
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