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510(k) Data Aggregation

    K Number
    K221576
    Device Name
    Ameda Pearl Electric Breast Pump
    Manufacturer
    Date Cleared
    2022-10-12

    (133 days)

    Product Code
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ameda, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ameda Pearl Electric Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Ameda Pearl Electric Breast Pump is intended for multiple users in a hospital setting. It is also intended for home use by a single user.
    Device Description
    The Ameda Pearl Electric Breast Pump is an electric breast pump powered by an external AC-DC power supply or its internal rechargeable lithium-ion battery. The device is provided non-sterile. The device is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on either one breast (single pumping) or both breasts at the same time (double pumping). The Ameda Pearl Electric Breast Pump utilizes a DC-powered motor driving a diaphragm-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide a range of user-selectable vacuum (suction) levels and pumping (cycle) speeds. Vacuum is monitored continuously by a sensor mounted on an internal printed circuit board. The Ameda Pearl Electric Breast Pump has a backlit LCD display, which shows pumping mode, suction level, cycle speed level, timer, and battery charge level. Surrounding the front panel display are eight soft-touch buttons allowing the user to power the device on/off, switch between stimulation and expression pumping modes, control vacuum strength and cycle speed, and adjust the lighting intensity of the LCD display and of a nightlight which shines from the underside of the pump handle. There are 6 levels of suction strength in stimulation mode and 12 levels in expression mode. While the user can select any of 6 available cycle speeds at each of the 12 vacuum levels in expression mode, the cycle speed in stimulation mode is pre-set at each of the 6 vacuum levels available in that mode. At minimum vacuum, level 1, the cycle speed is highest, 120 CPM (cycles per minute). Medium vacuum levels 2 and 3 are cycled at 100 CPM, and the highest 3 vacuum levels are delivered at 80 CPM. The Ameda Pearl Electric Breast Pump is primarily intended for multiple users in a hospital environment. Use is also expected in the home environment. When properly connected, the Ameda Hygienikit pumping kit transfers the vacuum generated by the powered pump to the breast enabling expression and collection of milk. A diaphragm in the breast flange assembly physically isolates pump and tubing from the air space where milk is expressed and collected, protecting the breast milk from contamination. The Ameda Pearl Electric Breast Pump is supplied with an AC adapter. HygieniKit is not included.
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    K Number
    K203570
    Device Name
    Mya Joy PLUS Breast Pump
    Manufacturer
    Date Cleared
    2021-04-22

    (136 days)

    Product Code
    Regulation Number
    884.5160
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ameda, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Ameda Mya Joy PLUS breast pump is a single-user, powered breast pump intended to express and collect milk from the breasts of lactating women.
    Device Description
    The Mya Joy PLUS Breast Pump is an electric breast pump powered by an external AC-DC power supply or by an internal rechargeable lithium ion battery. The device is provided non-sterile. The device is intended to be used by lactating women to express and collect milk from their breasts. Pumping can be performed on either one breast (single pumping) or both breasts at the same time (double pumping). The Mya Joy PLUS Breast Pump utilizes a DC-powered motor driving a diaphragm-type vacuum pump and an electromechanical solenoid which are controlled electronically to provide a range of user-selectable vacuum (suction) levels at various pre-determined cycle frequencies. The Mya Joy PLUS Breast Pump has a backlit LCD display, which shows pumping mode, suction level, timer, and battery level. The device also has four soft-touch buttons allowing the user to power the device on/off, switch between stimulation and expression pumping modes and control vacuum strength within each mode, 6 levels of vacuum strength in stimulation and 12 levels in expression. The Mya Joy PLUS Breast Pump is intended for a single user in the home environment. When properly connected, the Ameda Hygienikit pumping kit transfers the vacuum generated by the powered pump to the breast enabling expression and collection of milk. A diaphragm in the breast flange assembly physically isolates pump and tubing from the space where milk is expressed, flows and is collected, effectively protecting the breast milk from contamination. The pump allows lactating women to express milk at their own convenience and maintain their milk supply. The base model of the Mya Joy PLUS Breast Pump contains a pump, pumping kit, AC adapter with detachable USB-C cable, and a lanyard. Optional accessories, such as a carrying bag or spare parts for the pumping kit, may be included in the packaging of other product offerings.
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