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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device non-implanted electrical stimulation device for management of premature ejaculation
Regulation Description Non-implanted electrical stimulation device for management of premature ejaculation.
Definition A non-implanted electrical stimulation device for management of premature ejaculation is intended to be used in patients with premature ejaculation by delivery of electrical stimulation to the perineal muscles and nerves.
Product CodeQRC
Regulation Number 876.5026
Device Class 2


Premarket Reviews
ManufacturerDecision
MORARI, INC.
  SUBSTANTIALLY EQUIVALENT 1
VIRILITY MEDICAL
  GRANTED 1
VIRILITY MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1

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