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The Motive™ Muscle Stimulator for Lower Back is intended for the stimulation of healthy muscles to improve or facilitate muscle performance.

The Motive™ Muscle Stimulator for Lower Back is not intended to be used in conjunction with therapy or treat diseases or medical conditions of any kind.

The Motive™ Muscle Stimulator for Lower Back device is indicated for adults of 22 years of age and older.

The Motive™ Muscle Stimulator for Lower Back is an over-the-counter electrical muscle stimulator (or Neuromuscular Electrical Stimulation (NMES) therapy) used to stimulate healthy muscles to improve or facilitate muscle performance. The Motive Muscle Stimulator for Lower Back applies an electrical current through a power regulated output NMES system to strengthen muscles through repeated contractions. The device is placed over the applicable muscle groups to deliver NMES treatment to the user.

4.1 Electrical Muscle Stimulator (NMES therapy)

The Motive™ Muscle Stimulator for Lower Back (subject device) and the Motive™ Knee Wrap (reference device, K220738) utilize the same Controller and deliver an identical neuromuscular electrical stimulation (NMES) waveform, protocol, and pulse amplitude to strengthen muscles. The device uses a patented waveform, delivered through a power-regulated output and a closed-loop feedback NMES system, to stimulate healthy muscles and enhance muscle performance through repeated contractions. The waveform is generated by a pulse generator (Controller) and delivered non-invasively via electrodes placed on the skin. The patented waveform in the subject Motive™ Muscle Stimulator for Lower Back device is identical to the reference Motive™ Knee Wrap device. The NMES waveform information and rated outputs for both subject and reference devices are identical.

4.2 Mobile Application (App)

The electrical stimulation therapy is initiated and managed wirelessly by the User using the MyMotive™ App which is developed for use on smart devices that interact with the system's Controller.

4.3. Lower Back Electrodes / Therapy Pad

The Motive™ Muscle Stimulator for Lower Back (subject device) includes a custom-designed lower back therapy pad with three (3) cutaneous electrodes. This pad is made from the identical raw materials as the reference device's knee therapy pad (Motive Knee Wrap), differing only in its geometry. Like the Motive Knee Wrap, the Motive™ Muscle Stimulator for Lower Back therapy pad is supplied non-sterile, intended for single-patient use with multiple applications, and is disposable. During treatment, the pad is placed on the lower back and gluteus medius to deliver electrical stimulation when connected to the Controller.

4.4 Conductive Gel

The Conductive Gel is a salt-free, chloride-free gel designed for electromedical procedures such as NMES and TENS.

4.5 Wireless Communications

The Motive™ Muscle Stimulator for Lower Back device incorporates a Bluetooth Low Energy (BLE) connection module for wireless communication, allowing it to pair with a Bluetooth-enabled mobile device running the mobile application, available on App stores. The App provides a virtual control panel with on-screen buttons for user operation.

The Controller is connected to the Lower Back Electrodes / Therapy Pad through a proprietary interface featuring a keyed design with a magnetic force to ensure connection to the Controller's pogo pins. The Controller serves as the primary safety, ensuring stimulation output never exceeds IEC 60601-2-10 limits. The mobile application allows the user to adjust the treatment level to achieve comfortable muscle contractions. If the Bluetooth connection is lost, the Controller pauses treatment, and the mobile application alerts the user to check the device.

The Controller includes an LED indicator to display status relating to battery charge, stimulation, and Bluetooth activity. The Controller is powered by an internal 3.7V Li-Po rechargeable battery, which can be recharged via the USB-C port using the provided cable.

4.6 Software

The subject Motive Muscle Stimulator for Lower Back operates using embedded Controller firmware, a mobile App, and Web Services software. The Controller's embedded firmware is a core component that manages the selection, adjustment, and delivery of the treatment program. It runs on the Controller, interfacing with the stimulation pulse generator and the mobile application.

Available for free download from app stores (iOS and Android), the mobile application operates on a mobile platform and communicates with the Controller via a Bluetooth Low Energy (BLE) connection. It provides an intuitive interface for users to control the neuromuscular electrical stimulation (NMES) therapy, allowing them to select, administer, and adjust therapy intensities while managing health and wellness related to their treatment.

4.7 Controller and the App

The Controller's primary function is to generate neuromuscular electrical stimulation (NMES) therapy and transmit therapy metrics to the mobile App. Once the mobile application is installed and a wireless connection is established between the Controller and the user's mobile device, the user can access all device features.

The mobile application, downloaded from app stores (iOS or Android), provides an intuitive and interactive graphical user interface that manages interactions between the Controller and the user. Its design emphasizes user engagement and therapy compliance as key features. Help and informational screens are integrated throughout the App, appearing on specific screens to guide users about features or conditions.

Upon downloading the App, users are guided through a series of chronological screens to perform the following tasks such as setting up the device, selecting therapy options, and monitoring treatment progress:

• New user onboarding
• Review and acceptance of Product Warnings
• Reading and accepting the mobile application Terms of Use and Conditions
• Creating a user profile
• Pairing the App with the Controller
• Registering a therapy pad
• Device setup (therapy pad and controller placement over the applicable muscle group)
• Starting the treatment
• Managing the treatment

4.8 Web Services (API, Database)

The Motive™ Web Services, a Medical Device Data System (MDDS), enables the electronic transfer, storage, retrieval, and display of data from the user's App and Controller. It features an encrypted database hosted on secure cloud-based servers and an Application Programming Interface (API) that allows the mobile application to send, receive, read, or write data to the database and perform logic tasks. Web Services ensures persistent storage and retrieval of collected data.

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