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510(k) Data Aggregation
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The MOR System is indicated for the stimulation of healthy perineal muscles and nerves in adult males to improve or enhance sexual performance. It is not intended to be used in conjunction with therapy or treatment of medical diseases or medical conditions of any kind.
Device Description
The MOR System is a drug-free wearable patch system with single-use electrode patches, a reusable pulse generator, and a smartphone app. Together, these components deliver user-defined electrical stimulation to the perineal region.
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K Number
K223595Device Name
vPATCH
Manufacturer
Date Cleared
2023-05-01
(150 days)
Regulation Number
876.5026Why did this record match?
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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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K Number
DEN210012Device Name
vPatch
Manufacturer
Date Cleared
2021-11-23
(238 days)
Regulation Number
876.5026Why did this record match?
Product Code :
QRC
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. The vPatch contains electrodes that deliver electrical muscle stimulation (EMS) to the perineal muscles and nerves during intercourse to help the user postpone ejaculation. The patch works by delivering short duration. low intensity EMS to the target muscles and nerves. The stimulation contracts the pelvic floor muscles, which consequently, delays the rhythmic contractions of ejaculation. This increases the time between arousal and ejaculation. The vPatch is intended to be applied by the user to the perineum prior to intercourse and removed immediately after intercourse.
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