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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device non-medicated topical formulation for treatment of erectile dysfunction.
Definition A non-medicated topical formulation for treatment of erectile dysfunction is a device that is applied on the penis and stimulates the nerve endings by inducing a temperature change, leading to tumescence and erection.
Product CodeQWW
Regulation Number 876.5021
Device Class 2


Premarket Reviews
ManufacturerDecision
FUTURA MEDICAL DEVELOPMENTS LIMITED
  GRANTED 1

MDR Year MDR Reports MDR Events
2024 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1 1

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