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510(k) Data Aggregation
K Number
K052047Device Name
ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101
Manufacturer
AVENT AMERICA, INC.
Date Cleared
2005-09-22
(55 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
AVENT AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ISIS iQ UNO Handheld Electronic Breast Pump is intended to express and collect milk from the breasts of a lactating woman.
Device Description
The ISIS iQ UNO Handheld Electronic Breast Pump is a safe and effective powered breast pump used for expressing and collecting breast milk from the breasts of a lactating woman. The diaphragm within the pump is activated by a 6V DC electric motor controlled by a microprocessor. The device is comprised of a vacuum pump, 6V DC power supply, hand controller, Avent ISIS standard manual breast pump parts, and feeding bottles. The hand controller is designed to replicate the handle of the Avent standard manual ISIS Breast Pump, and is used to control the frequency and level of vacuum. A sealed AC/DC transformer or a battery pack powers the ISIS iQ UNO Breast Pump.
The ISIS iQ UNO Handheld Electronic Breast Pump operates in two modes. In the manual mode, the user controls the frequency and level of vacuum by varying the stroke/cycle of the control handle lever. After a comfortable manual pumping cycle has been established, the user engages the automatic pumping mode by depressing the control button on the hand controller. In the automatic mode, the pumping cycle is stored and controlled by the microprocessor. The user can switch between the automatic mode and manual mode at any time by repeatedly depressing the control button.
All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.
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K Number
K051413Device Name
ISIS IQ DUO TWIN ELECTRONIC BREAST PUMP, MODEL 100
Manufacturer
AVENT AMERICA, INC.
Date Cleared
2005-08-29
(90 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
AVENT AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ISIS iQ DUO Twin Electronic Breast Pump is intended to express and collect milk from the breasts of a lactating woman.
Device Description
The ISIS iQ DUO Twin Electronic Breast Pump is a safe and effective powered breast pump for expressing and collecting breast milk from the breasts of a lactating woman. The pumping can be performed on one breast or two breasts simultaneously, from independent diaphragms. The diaphragms within the pump are activated by a 12V DC electric motor controlled by a microprocessor. The device is comprised of a vacuum pump, 12V DC power supply, twin tubing with data cable, hand controller, Avent ISIS standard manual breast pump parts, and feeding bottles. The hand controller is designed to replicate the handle of the Avent standard manual ISIS Breast Pump, and is used to control the frequency and level of vacuum. A sealed AC/DC transformer powers the ISIS iQ DUO Breast Pump.
The ISIS iQ DUO Twin Electronic Breast Pump operates in two modes. In the manual mode, the user controls the frequency and level of vacuum by varying the strokelcycle of the control handle lever. After a comfortable manual pumping cycle has been established, the user engages the automatic pumping mode by depressing the control button on the hand controller. In the automatic mode, the pumping cycle is stored and controlled by the microprocessor. The user can switch between the automatic mode and manual mode at any time by repeatedly depressing the control button.
All milk-contacting and human tissue-contacting components are manufactured from materials that meet the appropriate regulations regarding food contact and/or biocompatibility.
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