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510(k) Data Aggregation

    K Number
    K252583

    Validate with FDA (Live)

    Manufacturer
    Date Cleared
    2026-03-12

    (209 days)

    Product Code
    Regulation Number
    884.5160
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Moon Wave (PA220) and Mini Moon (PA221) Electric Breast Pump is a personal use, electrically powered device used to express milk from the breasts of lactating women. This device is not intended for hospital use.

    Device Description

    PA220 – Moon Wave Electric Breast Pump: The PA220 is a countertop-style, electrically powered breast pump intended for single-user home use. The device incorporates dual-phase pumping (Stimulation and Expression modes), adjustable suction levels, and adjustable cycle speeds. It features a numeric LED display, programmable timer, night light, and an integrated silicone diaphragm backflow protection system. The PA220 is powered by a 12 V DC adapter or an integrated 7.4 V lithium-ion rechargeable battery pack (2S1P configuration).

    PA221 – Mini Moon Electric Breast Pump: The PA221 is a compact, wearable, electrically powered breast pump with a Slim-Cup hands-free collection system. The device incorporates dual-phase pumping (Stimulation and Expression modes) with adjustable suction levels and preset cycle speeds. It features LED suction level indicators and an integrated silicone diaphragm backflow protection system. The PA221 is powered by a USB-C 5 V adapter or an integrated 3.7 V lithium-ion rechargeable battery pack (1S1P configuration).

    Materials: The breast- and milk-contacting components of the device (e.g., flange, breast shield body, funnel base, collection bottle, cup, and diaphragm) are manufactured from polypropylene and silicone materials.

    AI/ML Overview

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