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For Prescription and Home Use by prescription from a medical professional:
The TrainFES advanced is a neuromuscular electrical stimulator indicated for use under medical supervision for adjunctive therapy in the treatment of medical diseases and conditions.

As a powered muscle stimulator, TrainFES advanced is indicated for the following conditions:

• Relaxation of muscle spasms
• Prevention or retardation of disuse atrophy
• increasing local blood circulation
• immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion
• Muscle re-education

As an external functional neuromuscular stimulator (FES), TrainFES Advanced is indicated for the following conditions:

• Helps to relearn voluntary motor functions of the extremities.

TrainFES' Advanced intended population is anybody aged 22 or over.

Environments of use: TrainFES Advanced devices can be used by both therapists and patients, in the clinic, hospitals or at home.

Platform: TrainFES is a battery-powered, wireless device, accessible through software.

TrainFES Advanced is a portable functional electrostimulator with 6 channels designed for use in the clinics and hospitals by the medical professionals as well as in the home environment by the patient. This device generates electrical impulses to stimulate the musculature of paralyzed seqments and facilitate both the relearning of movement and neuromodulation of tone.

TrainFES Advanced is a battery-powered, wireless device, configurable from the TRAINFES App, available for Smartphone and Tablets, which allows you to adjust different parameters and follow a training plan from your smartphone. Session settings can be retrieved from the PC or Cloud.

The provided document describes the FDA 510(k) premarket notification for the "TrainFES Advanced" device, a neuromuscular electrical stimulator. The purpose of this submission is to demonstrate substantial equivalence to a predicate device (Stella BIO, K210002).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" for the device's performance in a quantitative manner (e.g., target accuracy, sensitivity, specificity). Instead, the substantial equivalence justification relies on demonstrating that the TrainFES Advanced device performs similarly to or meets the safety and effectiveness standards of the predicate device, K210002.

The table below summarizes the comparison of key technical characteristics between the TrainFES Advanced and its predicate, Stella BIO, highlighting where "performance" is discussed in terms of meeting relevant standards or being considered equivalent. The reported "performance" for TrainFES Advanced is intrinsically linked to its compliance with these standards and the assertion that differences do not raise new safety or effectiveness concerns.

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