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510(k) Data Aggregation
Device Name
Motion InBra (YM-8801) wearable breast pumpManufacturer
Date Cleared
2026-02-13
(141 days)
Product Code
Regulation Number
884.5160Type
TraditionalAge Range
N/A
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview
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Device Name
Pump In Style® Pro+Manufacturer
Date Cleared
2026-01-22
(85 days)
Product Code
Regulation Number
884.5160Type
SpecialAge Range
All
Reference & Predicate Devices
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
The Pump In Style® Pro+ breast pump is a powered breast pump to be used by lactating women to express and collect milk from their breasts. The powered breast pump is intended for a single user. This breast pump is intended to be used in a home environment.
Device Description
Pump In Style Pro+ is a powered breast pump intended to be used in a home environment (or similar such as an office). It features 2-Phase Expression technology, which runs pumping in two phases (Stimulation and Expression) by applying a cyclic negative pressure to mimic a baby's natural nursing rhythm.
Pump In Style Pro+ comprises a pump unit, which includes:
- User-adjustable controls: "On/Off" for powering on/off the device, "Let-down" for switching between pumping phases, and "Increase vacuum"/ "Decrease vacuum" for controlling vacuum intensity levels;
- a port for connection of the tubing that channels the vacuum;
- a port for connection of the power supply;
- an internal, non-replaceable, rechargeable lithium-ion battery providing users the option to power the breast pump without reliance on a wall-connection or external power source;
- a LED battery status indicator which informs users of available charge;
- a pump phase LED status indicator which informs users of the active pump phase;
- vacuum level LED indicators (total of 16, one for each vacuum level).
Pump In Style Pro+ is a double electric breast pump that can be used to extract breast milk from one breast at a time (i.e., single pumping) or from both breasts simultaneously (i.e., double pumping). A DC (direct current) motor is used to drive a membrane aggregate. This membrane aggregate creates the negative pressure (suction) required to extract the breast milk.
The materials of the milk-contacting components are compliant with 21 CFR 177 and 21 CFR 178.
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