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Guidance Document for Powered Suction Pump 510(k)s

    https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-document-powered-suction-pump-510ks-guidance-industry-and-fda-reviewersstaff
    Powered Suction Pumps are described in the FDA regulations, 21 CFR 878.4780. A powered suction pump is a portable, AC-powered , or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may … See more

7 of the best erectile dysfunction pumps - Medical News …

    https://www.medicalnewstoday.com/articles/erectile-dysfunction-pump

    Vacuum Erection Device | Ed Pumps - Medical Department Store

      https://www.medicaldepartmentstore.com/Impotence-Aids-s/1596.htm
      We carry FDA approved and Physician recommended, medical Vacuum Erection devices, ED Pumps, lubricants and Tension Bands. All to help with the treatment of Erectile …

    External Penile Rigidity Devices Special Controls Guidance

      https://www.fda.gov/medical-devices/external-penile-rigidity-devices-class-ii-special-controls-guidance-document-industry-and-fda-staff
      External penile rigidity devices include vacuum pumps, constriction rings, and penile splints, which are mechanical, powered, or pneumatic devices. ... Aggravation of existing …

    Infusion Pumps | FDA - U.S. Food and Drug Administration

      https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/infusion-pumps
      Infusion Pumps. An infusion pump is a medical device that delivers fluids, such as nutrients and medications, into a patient’s body in controlled amounts. Infusion pumps are in …

    Penis pump - Mayo Clinic

      https://www.mayoclinic.org/tests-procedures/penis-pump/about/pac-20385225
      Penis pumps sold online, in magazines and sex ads might not be safe or work well. Make sure the penis pump you use has a vacuum limiter. This keeps …

    12 Best Penis Pumps for Erectile …

      https://www.healthline.com/health/erectile-dysfunction/best-penis-pump
      These Are the 12 Best Penis Pumps Money Can Buy, According to Experts. Criteria and cost. Before you buy. Air pumps. Water pumps. Manual pumps. Electric …

    Medical Grade Vacuum Device - Augusta Medical Systems

      https://augustams.com/medical-grade-vacuum-erection-device/
      Medical grade vacuum erection devices for erectile dysfunction also known as penis pumps are regulated by the Food and Drug Administration (FDA). They are …

    Non-powered Suction Apparatus Device Intended for …

      https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/non-powered-suction-apparatus-device-intended-negative-pressure-wound-therapy-npwt-class-ii-special
      FDA believes that a non-powered suction apparatus device intended for NPWT addressed by this guidance document is a significant risk device as defined in 21 CFR 812.3(m)(4). 4 …

    Medical Penis Pump. Androvacuum® …

      https://www.andromedical.com/androvacuum/medical-penis-pump/
      Androvacuum® is a medically proven, top quality penis vacuum pump. It is designed as a non-invasive, safe and effective product to use a part of a s exual fitness routine. …



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