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A mechanical walker used to provide moderate weight support while walking ensuring balance and support.

Series 400 Walker

This is a premarket notification for a mechanical walker (Series 400 Walker, K053192). The document confirms that the device is substantially equivalent to legally marketed predicate devices.

The information provided does not include acceptance criteria or a study proving the device meets said criteria, because this is a mechanical walker, not an AI/Software as a Medical Device (SaMD). The information requested in the prompt is specific to SaMDs or AI-powered devices, which are evaluated differently from mechanical devices. Mechanical walkers are evaluated based on established performance standards for safety and efficacy that are typically detailed in their 510(k) submission, but not in the FDA's decision letter itself.

Therefore, I cannot provide the requested information from the given text.

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