LogoFDA 510(k) Search
K Number
K093648
Device Name
SIMPLISSE ELECTRIC BREASTFEEDING COMPANION
Manufacturer
SIMPLISSE INC.
Date Cleared
2010-07-14

(231 days)

Product Code
HGX
Regulation Number
884.5160
Type
Traditional
Panel
OB
Reference & Predicate Devices
K950750,K973501,K983776
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

A personal use electric powered device used to express milk from the breast of lactating women. The device is not intended for hospital use

Device Description

The Simplisse Electric Breastfeeding Companion is a personal use electric powered device used to express milk from the breast of lactating women.

AI/ML Overview

§ 884.5160 Powered breast pump.

(a)
Identification. A powered breast pump in an electrically powered suction device used to express milk from the breast.(b)
Classification. Class II (performance standards).