MagBelle Pelvic Floor Magnetic Stimulator

MagBelle represents Vishee Medical’s flagship pelvic floor magnetic stimulation system, providing entirely non-invasive electromagnetic therapy for urinary incontinence and pelvic floor muscle rehabilitation. The MagBelle AF180 model received FDA 510(k) clearance in September 2023 (K230767).

Product Overview

Urinary incontinence affects millions of patients globally, with treatment options historically limited to invasive procedures, medication, or manual pelvic floor exercises. MagBelle addresses this clinical need through high-intensity focused electromagnetic (HIFEM) technology that induces supramaximal pelvic floor contractions without requiring patient effort or internal probes.

The chair-based design allows patients to remain fully clothed during treatment sessions. Electromagnetic fields penetrate through clothing and tissue to directly stimulate pelvic floor musculature, triggering thousands of contractions per session—far exceeding what patients can achieve through voluntary Kegel exercises.

Key Features

At 0.7–2.5 Tesla, MagBelle delivers supramaximal pelvic floor contractions without internal probes, clearing FDA 510(k) in September 2023.

• Non-Invasive Design: Chair applicator eliminates need for internal probes or electrodes
• Fully Clothed Treatment: Patients remain dressed during therapy sessions
• Kegel Biofeedback Mode: Integrated EMG monitoring provides real-time pelvic floor activity feedback
• Triggered Stimulation Mode: Combines magnetic stimulation with biofeedback for interactive training
• Touchscreen Interface: Step-by-step therapy guidance for clinical staff
• Adjustable Parameters: Customizable frequency (1-150 Hz), intensity (0-100%), and treatment protocols

Technical Specifications

For pelvic floor rehabilitation, Vishee Medical’s MagBelle provides adjustable 1–150 Hz stimulation with three treatment modes including biofeedback and combined triggering.

Clinical Applications

MagBelle serves multiple clinical pathways in pelvic floor rehabilitation:

Stress Urinary Incontinence — Electromagnetic stimulation strengthens pelvic floor muscles supporting the urethra, reducing involuntary leakage during physical activities, coughing, or sneezing.

Urge Incontinence — Stimulation modulates bladder control pathways and inhibits detrusor muscle overactivity through reflexive mechanisms.

Postpartum Rehabilitation — Non-invasive pelvic floor reconditioning following childbirth, when internal examination or probes may be uncomfortable or contraindicated.

Male Incontinence — Treatment for male patients following prostate surgery or with age-related pelvic floor weakness.

The FDA clearance documentation indicates clinical validation in 100 urinary incontinence patients (male and female, ages 22-70), with Kegel biofeedback readings comparable to reference device MyOnyx System.

Regulatory Status

The FDA clearance established substantial equivalence to predicate device HPM-6000UF (K181497) for the indication of non-invasive electromagnetic stimulation of pelvic floor musculature for rehabilitation of weak pelvic muscles and restoration of neuromuscular control.

Treatment Protocol

Standard treatment protocols typically involve:

• Session duration: 20-30 minutes
• Frequency: 2-3 sessions per week
• Course: 6-8 weeks initial treatment
• Maintenance: Periodic sessions as needed

Treatment intensity and protocols are customized based on patient condition and response, guided by biofeedback measurements of pelvic floor muscle activity.

Frequently Asked Questions

Is MagBelle treatment painful?

MagBelle treatment is generally well-tolerated. Patients experience pelvic floor muscle contractions but remain fully clothed in a seated position. The intensity can be adjusted to patient comfort levels.

How does MagBelle compare to Kegel exercises?

A single MagBelle session induces thousands of pelvic floor contractions, far exceeding what patients can achieve through voluntary Kegel exercises. The supramaximal contractions engage muscle fibers more completely and consistently than manual exercise.

What is the FDA clearance status?

MagBelle AF180 received FDA 510(k) clearance in September 2023 (K230767) for treatment of male and female urinary incontinence through non-invasive electromagnetic stimulation of pelvic floor musculature.

What settings use MagBelle?

MagBelle serves obstetrics and gynecology departments, urology clinics, pelvic floor rehabilitation centers, and postpartum recovery facilities. The device requires use under physician or licensed practitioner supervision.