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510(k) Data Aggregation
K Number
K113315Device Name
RUMBLE TUFF
Manufacturer
Date Cleared
2012-11-20
(377 days)
Product Code
Regulation Number
884.5160Why did this record match?
Applicant Name (Manufacturer) :
ACUTE IDEAS CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Rumble Tuff Electric Breast Pump is an electrically powered single-user device used to express and collect milk from the breasts of lactating women. The device is not intended for hospital use.
Device Description
The Rumble Tuff Electric Breast Pump is a powered Breast Pump. With different models, the Pumping can be performed on one breast or on both breasts at the same time; the Rumble Tuff Electric Breast Pump can be powered by 4 AA batteries, one 7.4V Li batteries or an AC Adapter provided with the pump. The pumping system consists of a diaphragm-type vacuum pump which is driven by a microcontroller controlled DC electric motor. Rumble Tuff Electric Breast Pump has five models; PA200S, PA201S, PA201D, PA203S, and PA203D. The suffix "S" stands for the model with single collection kit, and "D" stands for the model with dual collection kits. The user interface of PA200S uses 4 LEDs for indicating pumping cycle and uses a roller type adjuster for pumping level adjustment and indicating pumping level. Models PA201S, PA201D, PA203S, and PA203D all use the same user interface, a LCD screen for showing the pumping information; it also uses a roller type adjuster for pumping level adjustment. For all models, the user is able to control the cycle speed and vacuum level.
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K Number
K023711Device Name
DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE
Manufacturer
Date Cleared
2002-11-21
(17 days)
Product Code
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
ACUTE IDEAS CO. LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Device measures the human body temperature from oral, axillary, and rectal. -The device is reusable and intended for clinical or home use on people of all ages.
Device Description
The Digital Thermometer is an electronic clinical thermometer intended for the determination of oral, axillary, and rectal body temperature determination in humans. Classic type and Flexible type have the same indication for use; however, Flexible type has a flexible tip.
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