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510(k) Data Aggregation
K Number
K191577Device Name
Willow Wearable Breast Pump 2.0
Manufacturer
Exploramed NC7, Inc.
Date Cleared
2019-09-06
(84 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Exploramed NC7, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Willow Wearable Breast Pump 2.0 is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
Device Description
The Willow Wearable Breast Pump 2.0 (Willow) is a small electric breast pump that is intended for lactating women to express and collect breast milk. Willow may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, she would need to use two Willow devices at the same time, one on each breast. Willow is for use by a single user only.
Willow is a battery-powered electro-mechanical device that contains software. The device includes the following main components: Pump, milk collection component (milk bag or container), and a charger.
All milk contacting components of the device are compliant with 21 CFR 174-179.
This submission was for clearance of modifications made to the predicate device, including addition of a milk container for milk collection, updates to device firmware, inclusion of Bluetooth for connection to an optional mobile app, and a change in the flange attachment method.
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K Number
K161266Device Name
Athena Breast Pump
Manufacturer
EXPLORAMED NC7, INC
Date Cleared
2016-08-11
(98 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
EXPLORAMED NC7, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ExploraMed NC7 Athena Breast Pump is intended to express milk from lactating women in order to collect milk from their breasts. The device is intended for a single user.
Device Description
The ExploraMed NC7 Athena Breast Pump (Athena) is a small electric breast pump that is intended for lactating women to express and collect breast milk. The subject device is intended for multiple uses with a single user. Athena may be operated as a single or double pumping system. For a user to pump both breasts simultaneously, she would need to use two (2) Athena devices at the same time, one on each breast.
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