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The FastFit EMS System is intended to stimulate healthy muscles in order to improve or facilitate muscle performance.

It is not intended to be used in conjunction with therapy or treatment of medical conditions of any kind. None of the stimulation programs or operational parameters are designed to target injured or ailing muscles and its use on such muscles is contraindicated.

The FastFit EMS System is Rx only.

The EMS System is a series of electrical muscle stimulation (EMS) electrodes embedded in a compression textile body suit intended to be worn by a user during physical exercise. When operated, the device provides localized electrical muscle stimulation (EMS) pulses to major muscle groups at controllable intensities. When operated, the device provides localized EMS pulses to major muscle groups at controllable intensities. The FastFit EMS system consists of the following primary components:

• FastFit Exercise Suit
• EMS Controller
• Power Adaptor
• FastFit Software Application

The FastFit Exercise Suit is a full body compression garment made from a Nylon/Spandex stretch fabric that incorporates embedded electrodes over key muscle groups. These electrodes are constructed of a conductive fabric sewn over a foam pad. Each electrode is connected via an integrated set of wiring leads sewn into the suit fabric that connect to a central contact pad at the right hip of the suit. A suit-to-controller connector at the central contact pad has 10 pairs of pins that act as lead contacts. Once connected to the suit, the EMS controller can deliver EMS pulses at the programmed intervals.

EMS pulse intensity and target locations are controlled via a Bluetooth connection with a user's smartphone installed with the FastFit software application. A graphic user interface displayed on the touchscreen of the smartphone allows for the user to customize the stimulation program parameters at their discretion. After stimulation parameters have been set by the user with the software application, the parameters are uploaded to the EMS controller, and stimulation can be started anytime at the discretion of the user. The EMS controller is powered by a rechargeable lithium ion battery. A separate with an AC power adapter is provided to recharge the EMS controller when not in use.

This document is a 510(k) Summary for the FastFit EMS System, seeking substantial equivalence to existing predicate devices. It does not contain information about acceptance criteria or a comparative study proving the device meets specific performance metrics in a clinical or AI-assisted context.

Therefore, I cannot provide the requested information as the document does not describe acceptance criteria or a study proving the device meets such criteria.

The document focuses on demonstrating substantial equivalence based on:

• Indications for Use: The FastFit EMS System is intended to stimulate healthy muscles to improve or facilitate muscle performance, similar to the predicate devices.
• Technological Features: A detailed comparison of the FastFit EMS System with its predicate devices (Compex® Wireless USA and Katalyst Mark 1 Muscle Stimulation System) regarding their design, power source, charging, output specifications, and interfaces.
• Nonclinical Testing: Summary of tests performed including system design verification, software verification/validation, electrical safety, electromagnetic compatibility, biocompatibility, and usability/human factors testing. These tests confirm the device's basic functionality and safety, but not its performance against specific acceptance criteria for efficacy in a clinical setting with human subjects or AI-assisted readings.

The document explicitly states: "The information and data provided in this 510(k) submission identifies no new safety or effectiveness issues. Based on the above information, FastFit believes that the substantial equivalence of the FastFit EMS system to the Compex Wireless USA and Katalyst Mark 1 has been demonstrated." This indicates the submission is for regulatory clearance based on substantial equivalence, not for demonstrating specific performance metrics against pre-defined acceptance criteria through a comparative study.

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