Search Results
Found 1 results
510(k) Data Aggregation
K Number
K243079Device Name
NeuroTrac® MyoPlus Pro (MYO120U)
Manufacturer
Verity Medical Ltd.
Date Cleared
2025-06-26
(269 days)
Product Code
N/A
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Verity Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
STIM: Electrical stimulation and neuromuscular re-education for the purpose of rehabilitation of weak pelvic floor muscles for the treatment of stress, urge and mixed urinary incontinence in adult women.
EMG: Relaxation muscle training and muscle re-education.
ETS: Treatment of stress, urge or mixed urinary incontinence by assessing EMG activity of the pelvic floor and strengthening pelvic floor muscles using electrical stimulation.
This device is intended to be used by adult women (aged above 22 years).
Device Description
The NeuroTrac® MyoPlus Pro is a single-channel pelvic floor muscle stimulator (STIM) designed to assist patients with urinary incontinence to increase muscle control and overcome pelvic muscle dysfunction. It can also act as an electromyograph (EMG) and features an EMG-triggered stimulation (ETS) mode. The stimulation waveform is symmetrical, rectangular and biphasic. Stimulation is delivered using a vaginal probe. The vaginal probe included with the subject device was cleared under K122194. The subject device may either be operated directly by the prescribing physician, or by the patient as instructed by the physician.
Ask a Question
Page 1 of 1