Search Results

The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with mild, moderate, and severe stress urinary incontinence

The Flyte System is a repeat use, non-sterile, vaginal device intended to condition and strengthen the pelvic floor muscle (PFM) system to treat women with urinary incontinence. The Flyte System is designed for in-home use to deliver treatment to the pelvic floor muscles during normal Kegel exercises. The product consists of an intravaginal wand and a hand-held controller. The Flyte wand is placed in the vagina and, under the direction of the controller, delivers a series of mechanical vibrations while the pelvic floor muscles are contracting. This treatment is called mechanotherapy. The Flyte controller controls the wand, guides the user through the treatment session and provides visual information to inform the user when the correct muscles are being contracted during a Kegel exercise. The wand is designed to make optimal contact within the vaginal canal and to deliver vibrations via an eccentric weight driven by an electric motor which causes the wand to oscillate at a specific frequency as directed by the controller. The wand additionally provides a resistive surface against which the user can contract the PFM. A cable connects the wand and the controller. Controller: The controller consists of a 3.7V Lithium-ion Polymer rechargeable battery with a capacity of 700-750 mAh and built-in safety protection. The controller also contains a PCB assembly used to control the motor speed and frequency and to provide the user with visual information. The controller housing is made of ABS plastic (Acrylonitrile-butadiene-styrene copolymer). Wand: The wand contains an accelerometer and gyroscope which enable the Controller to generate visual information. It also houses the motor and weight used to generate mechanical vibrations. The wand is available in large and small sizes. The wand housing is cylindrical and is made of ABS plastic. The wand is the only part of the device that directly contacts the user's vaginal cavity (mucosal membrane contact, <24hr) and is covered entirely with a biocompatible medical-grade silicone sheath. Additional Components: Charging Cable: Connects the Controller to the Charging Block Charging Block: AC adapter that allows you to plug the Controller into a wall outlet for charging. Optional Flyte App and Provider Portal: The Flyte App is a mobile application that provides an optional additional interface for the user. The Flyte App enables the user to create an account, pair the App with the Controller, and view general Flyte information and instructions. The Controller provides information to the App, unidirectionally. During a treatment session, the Flyte App provides an optional additional interface guiding the user through the treatment session and providing information to inform the user when correct muscles are being contracted and relaxed during the session. The Flyte App also collects two patient reported outcomes surveys at regular intervals over the treatment period. The Flyte App enables the user to view treatment history, including dates a treatment session was completed, contraction and relaxation data from those sessions, and the patient reported outcomes data. The Flyte App stores data in an encrypted database on the device, and securely uploads data to a secure, HIPAA-compliant cloud database. The Flyte App is not required for use of the Flyte System. The Flyte Provider Portal is a HIPAA-compliant web portal that enables providers to send invitations to users/patients for Flyte App registration. If a user accepts the provider's invitation and provides consent during registration, the Flyte Provider Portal enables the provider to view historical treatment and patient reported outcomes data for that user. The Flyte Provider Portal is not required for use of the Flyte System.

The Flyte System is intended for strengthening of the pelvic floor muscles to treat women with stress urinary incontinence.

The Flyte System is a repeat use, non-sterile, vaginal device intended to condition and strengthen the pelvic floor muscle (PFM) system. The Flyte System is designed for in-home use to deliver treatment to the pelvic floor muscles during normal Kegel exercises. The product consists of a wand and a hand-held controller. The Flyte wand is placed in the vagina and delivers a series of mechanical vibrations while the pelvic floor muscles are contracting. The hand-held controller controls the wand, guides the user through the treatment session and provides a visual feedback function to inform the user when the correct muscles are being contracted during a Kegel exercise. The wand provides a resistive surface against which the user can contract the PFM, and houses an electric motor containing an eccentric weight that generates mechanical oscillations when the motor is running. A cable connects the wand and the controller.

The Pelvital System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.

Not Found

The Pelvital Flyte™ System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.

Not Found

The Pelvital System is intended for the strengthening of the pelvic floor muscles, which has been found to help women with stress urinary incontinence.

The Pelvital System is a repeat use, a non-sterile vaginal device intended to condition and strengthen the pelvic floor muscle (PFM) system. The model MTI-1 is designed for in-home use to enhance PFM training during normal Kegel exercises. The product consists of a probe that is inserted into the vagina and a handheld control unit that provides a biofeedback function to inform the correct muscles are being contracted during a Kegel exercise. The probe is designed to provide a resistive surface against which the user can contract the PFM, and an electric motor containing an eccentric weight that causes the probe to oscillate . The probe and the control unit are connected by a cable. Control Unit: The control unit consists of a 3.7V Lithium-ion Polymer rechargeable battery with a capacity of 680-710 mAh and built-in safety protection. The unit also contains a PCB assembly used to control the motor speed and frequency and to provide the user with the biofeedback information. The control unit housing is made of ABS plastic (Acrylonitrile-butadiene-styrene copolymer). Probe Unit: The probe unit contains an accelerometer and gyroscope which generate the biofeedback information. It also houses the motor and weight used to generate oscillations. The maximum diameter is 36 mm, and the maximum length is 100 mm. The design includes a winged flange that limits the maximum insertion length to 88 mm. The probe housing is cylindrical and is made of ABS plastic. The probe is the only part of the device that directly contacts the user's vaginal cavity (mucosal membrane contact, ≤24hr) and is covered entirely with a biocompatible medical-grade silicone sheath.