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The ReWalk™ orthotically fits to the lower limbs and part of the upper body and is intended to enable individuals with spinal cord injury at levels T7 to L5 to perform ambulatory function of a specially trained companion in accordance with the user assessment and training certification program. The device is also intended to enable individuals with spinal cord injury at levels T4 to perform ambulatory functions in rehabilitations in accordance with the user assessment and training certification program. The ReWalk™ is not intended for sports or stair climbing.

The ReWalk™ orthotically fits to the lower limbs and part of the upper body.

This document is an FDA 510(k) clearance letter for the ReWalk™ Powered Lower Extremity Exoskeleton. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in a clinical study report or a summary of safety and effectiveness (SSED).

The letter primarily confirms that the FDA has reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices for its stated indications for use. It lists the regulation number, product code, and regulatory class, and outlines general controls provisions of the Act that apply to the device.

Therefore, I cannot provide the requested information based on the provided text. The document is an administrative regulatory clearance, not a technical report detailing performance and validation studies.

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