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510(k) Data Aggregation
K Number
K230672Device Name
Annabella Breast Pump
Manufacturer
Date Cleared
2023-08-04
(147 days)
Product Code
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Annabella Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Annabella Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Annabella Breast Pump is intended for a single user.
Device Description
The Annabella Breast Pump is a single, electric breast pump system intended to express and collect milk from the breasts of lactating women. It is comprised of a vacuum unit including tubing and a massage unit that mimics the baby's sucking motions. The user employs buttons on the vacuum unit to control the vacuum intensity levels, suction rate as well as the massage unit speed and location on the breast. The device is supplied with a reusable, washable and adjustable breast shield, a bottle lids and a charger. The Annabella is a rechargeable Li-ion battery operated device that contains software. The device cannot be operated while connected to the mains AC Power core. The battery compartment is at the bottom of the pump motor unit and is covered by a battery door. The runtime of the removable lithium-ion battery is influenced by the number and duration of pumping sessions and lasts usually for one day. The device is to be used in the home.
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