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The ReWalk™ P6.0 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 functions with supervision 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 T6 to perform ambulatory functions in rehabilitation institutions in accordance with the user assessment and training certification program. The ReWalk™ is not intended for sports or stair climbing.

The ReWalk™ P6.0 is a prescription device which enables individuals with spinal cord injuries to perform ambulatory functions and composed of an external, powered, motorized frame fits to the lower limbs and part of the upper body. Control of the device is achieved through a wrist-worn user-operated wireless remote controller (RC), tilt sensor and specific body movements. The gait movements are performed by a set of gears and motors at the knee and the hip joints. The ReWalk™ P6.0 system includes Remote control (RC) Communicator, Exoskeleton (Inc. Rigid Frames, Waistpack and Straps), Battery charger and Laptop (GUI).

The provided text is a 510(k) summary for the ReWalk P6.0 exoskeleton. It establishes substantial equivalence to a predicate device (also a ReWalk P6.0, K160987). However, the document does not contain specific acceptance criteria or the details of a study with performance data that proves the device meets those criteria.

The document primarily focuses on establishing substantial equivalence based on comparisons of indications for use, technological characteristics, and conformity to recognized standards, rather than presenting original performance data against specific acceptance criteria.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor details about a study proving this performance, as that information is not present in the provided text.

Specifically, the document states:

• "The only differences between the ReWalk™ and its predicate are two (2) minor software modifications for sit-to-stand transition, and the addition of one (1) new software feature for stand-to-sit transition. These minor differences do not present any new or different questions of safety or effectiveness as confirmed by completed testing also discussed in further detail below."
• "Review of non-clinical performance testing as well as comparison of the device classification, indication for use, operating principles, technological characteristics demonstrate that the subject device is substantially equivalent to the predicate. Any differences between the subject and the predicate device do not raise new questions of safety or effectiveness."

These statements imply that testing was done to confirm safety and effectiveness related to the software changes, but the document does not detail the acceptance criteria for those tests or the results of those tests. It refers to "completed testing also discussed in further detail below," but this "further detail" is not present in the provided excerpts.

The document mainly lists standards that the device is designed to fulfill (e.g., IEC 60601-1-11:2015, IEC 60601-1-2, ANSI AAMI ES 60601-1:2005, ISO 14971, IEC 62304) and asserts that "Performance data are available to assess the effects of the new characteristics" and "Performance data (along with descriptive characteristics) demonstrate substantial equivalence," but these data are not included.

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