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510(k) Data Aggregation
K Number
K221598Device Name
Wearable breast pump
Manufacturer
Date Cleared
2022-12-09
(190 days)
Product Code
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
Mayborn (UK) Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Wearable Breast Pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. It is intended for a single user.
Device Description
The Wearable Breast Pump (model: 1203) is an electric breast pump system comprised of a single or double portable unit that integrates the pump body and milk collection bottle. It consists of a pump (motor unit) and includes a breast shield, bottle, seal, valve, spout, and bra adjuster. All components (minus the pump) are reusable and may be manually cleaned. The Wearable Breast Pump includes rotary electric pump technology which generates negative pressure on the nipple to express milk, which is collected in the integrated milk collection bottle. It is designed to work in the user's nursing bra and has a rechargeable battery so it can be used hands-free without external power cords or milk collection tubes. The Wearable Breast Pump is a battery-powered electro-mechanical device that can be controlled through the physical interface on the device or through a mobile companion app, which also provides real-time milk monitoring, pump battery life, pumping time elapsed, and pumping history information. All milk contacting components are constructed out of food grade materials that are compliant with 21 CFR 174-179.
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