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510(k) Data Aggregation
K Number
K223595Device Name
vPATCH
Manufacturer
Date Cleared
2023-05-01
(150 days)
Regulation Number
876.5026Why did this record match?
Applicant Name (Manufacturer) :
Virility Medical, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The vPatch is indicated for management of premature ejaculation in males who ejaculate after intromission. It is designed to increase the time between arousal and ejaculation by delivery of short duration, low-intensity electrical stimulation to the perineal muscles and nerves during intercourse.
Device Description
The vPATCH is a single-use disposable patch designed to manage premature ejaculation. It contains electrodes that deliver electrical muscle stimulation (EMS) to the perineal muscles during intercourse to help the user postpone ejaculation. The patch works by delivering shortduration, low-intensity EMS to the perineal muscles and nerves during intercourse. The stimulation contracts the pelvic floor muscles, which consequently delays rhythmic contractions of ejaculation. This increases the time between arousal and ejaculation. The vPATCH is comprised of several layers which include the cover, electrical circuit board including batteries, and adhesive electrodes. The skin-contacting materials are hydrogel, polyolefin foam, and thermoplastic elastomer (TPE). The vPATCH is available in two intensity levels (High and Low).
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