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The XBODY NEWAVE USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and people (clients), not for rehabilitation purposes.

The XBODY NEWAVE USA is intended to stimulate healthy muscles in order to improve or facilitate muscle performance The XBODY NEWAVE USA is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind. None of the XBODY NEWAVE USA training programs is designed for injured or ailing muscles and its use on such muscles is contraindicated.

The XBODY NEWAVE USA electrical impulses allow the triggering of action potentials on motoneurons of motor nerves (excitations). These excitations of motoneurons are transmitted to the motor endplate where they generate mechanical muscle fiber responses that correspond to muscle work. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, total session duration), different types of muscle work can be imposed on the stimulated muscles.

The various types of muscle work that the XBODY NEWAVE USA can impose on the stimulated muscles are able to improve or facilitate muscle performance. The XBODY NEWAVE USA may therefore be considered a technique of muscle training.

The XBODY NEWAVE USA is a machine with electronic muscle stimulation based on EMS technology. The device is specifically designed as an addition to other sports and for training muscles. It must be used for only healthy muscles and clients, not for rehabilitation purposes.

This document is a 510(k) premarket notification for the XBODY NEWAVE USA device. It does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device. Instead, it demonstrates substantial equivalence to a predicate device, a common pathway for medical device approval where the device is shown to be as safe and effective as a legally marketed device.

Therefore, I cannot extract the requested information using only the provided text, as it describes a different type of regulatory submission. The request asks for details typically found in AI/ML performance studies, which are not present in this 510(k) for a powered muscle stimulator.

Here's why the document doesn't contain the requested information:

• Device Type: The XBODY NEWAVE USA is a "Powered Muscle Stimulator" (Product Code NGX, Regulation Number 21 CFR 890.5850). This is a physical device, not an AI/ML algorithm.
• Regulatory Pathway: The document describes a 510(k) submission, which focuses on demonstrating "substantial equivalence" to a predicate device. This typically involves comparing technological characteristics, intended use, and safety/performance standards. It does not require a clinical study with acceptance criteria for AI/ML performance metrics like sensitivity, specificity, accuracy, or reader improvement.
• Absence of AI/ML Specifics: There is no mention of AI, machine learning, algorithms, or any data-driven diagnostic or prognostic capabilities. The document details electrical impulses, physical parameters, user interfaces, and safety standards for the muscle stimulator.

To answer your request, I would need a document describing the regulatory submission for an AI/ML medical device, which would include performance metrics and clinical validation studies.

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