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510(k) Data Aggregation
K Number
K230570Device Name
Willow Generation 3 Breast Pump
Manufacturer
Willow Innovations, Inc.
Date Cleared
2023-10-16
(229 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Willow Innovations, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Willow® Generation 3 Breast Pump is intended to express milk from lactating women in order to collect breast milk from their breasts. The device is intended for a single user.
Device Description
The Willow Gen 3 is a small electromechanical breast pump intended for lactating women to express and collect breast milk. It is a reusable single user device which is provided non-sterile. The device consists of a Pump, Flange, Flextube, and either Milk Bag (single use, disposable) or Milk Container (multiple use, reusable) assembled into one unit and is designed to fit on the user's breast. The pump component does not come into direct or indirect contact with the breast milk. Users can pump one breast using one Willow Pump or pump both breasts simultaneously using two Willow pumps. The device operates on a battery which can be charged with the provided charger using a standard 120V wall outlet. Two pumping modes are provided: stimulation and expression. The pump is controlled by the user through either the tactile buttons on the pump or optionally through the Mobile App or Apple Watch App.
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K Number
K213311Device Name
Lucy Breast Pump
Manufacturer
Willow Innovations, Inc.
Date Cleared
2022-02-09
(128 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Willow Innovations, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lucy Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The Lucy Breast Pump is intended for a single user.
Device Description
The Lucy Breast Pump (Lucy) is a cordless, software-controlled, battery powered breast pump that is intended for use by lactating women to express and collect breast milk. The Lucy Breast Pump is intended for a single user and provided as a non-sterile device. The user has the option to pump from one breast (single pumping) or two breasts simultaneously (double pumping). The fully assembled Lucy Breast Pump, consisting of the Flange, Pump Body, Pump Diaphragm, and Container Assembly, is designed to work in the user's nursing bra that allows it to be used handsfree. The Lucy Breast Pump provides two operational modes (stimulation and expression), with three vacuum/cycle levels in stimulation mode and four vacuum/cycle levels in expression mode. Switching between modes and changing the levels within each mode is done through the physical interface on the pump.
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