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510(k) Data Aggregation
K Number
K132220Device Name
PJ'S SERENITY
Manufacturer
LIMERICK, INC.
Date Cleared
2015-02-20
(583 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
LIMERICK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electric Breast Pump, model PJ2012 is used to express and collect milk from the breast to alleviate engorgement of the breast, maintain the ability of lactation and provide mother's milk for future feeding when separation of mother and baby occurs. The device is intended for multiple uses.
Device Description
The Electric Breast Pump, model PJ2012 is designed and manufactured by Limerick, Inc. It is intended to express and collect milk from a lactating woman's breast. This action helps to alleviate engorgement of the breast, maintain the woman's ability to lactate, and provide a mother's milk for future feedings when separation of the mater and baby occur.
The product uses a Single-Chip Microcontroller to imitate a baby's suckling action. The device is ergonomically designed to create comfortable milk stimulation, massage, and suction from the breast. There are 80 vacuum levels and 30 speeds available to imitate the rhythm and action of a baby's suckling. Selection of the vacuum and speed is made by adjusting the control knobs on the front panel of the pump. The control panel is soft and viewing is provided by a LCD screen. Once programmed, the pump's electronic memory stores the selected rhythm and intensity of the device.
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K Number
K051926Device Name
LIMERICK PJ'S COMFORT JR PORTABLE ELECTRIC BREAST PUMP
Manufacturer
LIMERICK, INC.
Date Cleared
2005-12-12
(147 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
LIMERICK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the electrically powered suction device is to express milk from the breast.
The intended use of the electrically powered suction device is to lactating women.
Device Description
The pj's comfort jr® Portable Electric Breast Pump is powered by a variable speed DC motor that drives a high vacuum pump similar to that used in the pj's comfort® breast pump that has 510(k) approval # K012275. The vacuum part of the vacuum pump is interconnected with a PIC 16F872 microprocessor controller circuit, and a solenoid valve that provide variable speed vacuum cycling rates, from 16 to 70 cycles per minute, by way of the control panel. A second knob located on the front panel provides for user selection of infinitely variable maximum vacuum levels from 90 to 270 mm Hg. The minimum vacuum is always 40 mm Hg. The vacuum is the same for single and double pumping. When the cycle knob and the vacuum knob are both set at maximum the maximum vacuum is approximately 270 mm Hg. and the cycle speed is 16 cycles per minute. When the cycle knob is set at maximum and the vacuum knob is set at minimum, the maximum vacuum is approximately 90 mm Hg. and the cycle speed is 70 cycles per minute. When the cycle knob is set at minimum, and the vacuum knob is set at maximum, the maximum vacuum is approximately 270 mm Hg. and the cycle speed is 16 cycles per minute. When the cycle knob and the vacuum knob are both set at minimum, the maximum vacuum is approximately 40 mm Hg. and the cycle speed is 36 cycles per minute. The controller contains firmware, loaded at the factory in non-volatile memory, and requires no software to be loaded at each startup. The pj's comfort ® breast pump with 510(k) approval # K012275 uses discrete electronic components to carry out similar control functions. The above controls allow the user of the pj's comfort jr.® to mimic the speed and strength of sucking of their infant, and to maximize their comfort. A maximum vacuum of 270 mm Hg. is applied to one or both breasts by way of flexible tubing to the breast cup(s). The pj's comfort jr® front control panel also has a set of indicator lights that show the time remaining in the pumping session. These lights also indicate a particular pattern in case of pump failure. - Top three lights flashing: Excess vacuum level; not user repairable, return to factory for repair. - Middle three lights flashing: Blocked tubing or replace filter. - Bottom three lights flashing: Pump overheated: turn pump off and allow to cool. If this happens often, return pump to factory for repair. The pj's comfort jr® Portable Electric Breast Pump can be operated by use of either an AC/DC wall converter, a 12-Volt battery pack or a 12 volt motor vehicle adapter. All materials used in the manufacturing of this device that have contact with food or human tissue meet requirements of the FDA and or biocompatability.
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K Number
K021739Device Name
LIMERICK POWERED ELECTRIC BREAST PUMP MODEL 1002
Manufacturer
LIMERICK, INC.
Date Cleared
2003-01-10
(227 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
LIMERICK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the electrically powered (diaphragmtype) suction device is to express milk from the breast of lactating women.
Device Description
This portable electric breast pump model 1002 is powered by a variable speed DC motor that drives a diaphragm pump. The diaphragm pump creates the negative pressure reguired to extract breast milk. This pump has variable speed cycling rates, which is controlled by a knob located on the control panel. The breast pump is capable of providing multiple vacuum levels, which are user selectable by use of a knob located on the front panel. A maximum vacuum of 250-mm Hg. is applied to one or both breast through a disposable filter that is connected by way of flexible tubing to the breast cup(s).
It can be operated by use of either an AC/DC wall converter or a 12-Volt battery.
All materials used in the manufacturing of this device that has contact with food or human tissue meet requirement of the FDA and international regulations concerning food contact and/or biocompatability.
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K Number
K012275Device Name
PJ.S COMFORT PORTABLE ELECTRIC BREAST PUMP
Manufacturer
LIMERICK, INC.
Date Cleared
2002-01-07
(172 days)
Product Code
HGX
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
LIMERICK, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the electrically powered (diaphragm-type) suction device is to express milk from the breast of lactating women.
Device Description
pj.s comfort® Portable Electric Breast Pump (suction device with a compressor unit) contains a diaphragm-type pump with a vacuum regulator (between 150mm unity oontaine a clapmelling a filter, soft silicone tube and plastic tubing. An accessory kit includes silicone breast cups and a collection cup. The device is battery and line-powered for 12V DC by an external transformer or utilizes a 12V-battery pack. The device is controlled by an electric sensor with intermittent suction at approximately 30-45 cycles. The bacterial filter contains an optical sensor, with an automatic shut off. The motor stops when liquid is sucked into the bacterial. The pump can be used with the Single Breast Pump Kit #6166-3 or the Double Breast Pump Kit #6166-0. Dimensions are 7 x 12 x 3 .5 inches and the weight is 4.5 lbs. Suction is controlled by the pump automatically. It will automatically be released when the adjusted vacuum is reached. An electronic sensor is built-in for automatic motor shut off: If milk flows into the bacterial filter, the motor stops automatically at once and the inside valves from the pump cannot be damaged through the milk. The bacterial filter should be changed regularly.
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