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The PowerDot PD-01 device, used with PowerDot Mobile Application, is intended for the stimulation of healthy muscles in order to improve or facilitate muscle performance. The PowerDot PD-01 device and PowerDot Mobile Application are not intended to be used in conjunction with therapy or treatment diseases of medical or medical conditions of any kind.

PowerDot PD-01 Muscle Stimulator is a battery-powered neuromuscular stimulator intended to stimulate healthy muscles in order to improve or facilitate muscle performance and, with that regard, may be considered a technique or method for muscle training. PowerDot PD-01 device is designed to be used together with PowerDot Mobile Application. PowerDot PD-01 device uses Bluetooth™ Low Energy (Bluetooth 4.0, Class II) wireless radio frequency protocol for communication with supported range of mobile devices (such as smartphones and/or tablets) via PowerDot Mobile Application. Accessories include lead cables of 2 different lengths, USB charging cable, 2 types of hydrogel-based self-adhesive electrode pads and carrying case.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you are asking. The document is a 510(k) premarket notification decision letter from the FDA, and it focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance study results.

Here's a breakdown of why I cannot fulfill your request with the given information:

• Acceptance Criteria and Reported Device Performance: The document provides a comparison table between the PowerDot PD-01 and a predicate device (Compex Sport Plus) for various technical parameters. However, these are comparative features, not specific acceptance criteria with quantitative performance metrics. For example, for "Patient Leakage Current," it states "

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