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510(k) Data Aggregation
K Number
K212609Device Name
BHA100 Series Braun Clear Hearing Aid
Manufacturer
Kaz USA, Inc., a Helen of Troy Company
Date Cleared
2022-01-05
(141 days)
Product Code
QDD
Regulation Number
874.3325Why did this record match?
Applicant Name (Manufacturer) :
Kaz USA, Inc., a Helen of Troy Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BHA100 Series Braun® Clear™ Hearing Aid is a self-fitting, air conduction hearing aid, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. It is adjusted by the user to meet the user's hearing needs. The device is intended for direct-to-consumer sale and use without the assistance of a hearing health care professional.
Device Description
The BHA100 Series Braun® Clear™ Hearing Aid is a self-fitting, air conduction hearing aid. It features digital signal processing (16 channel-wide dynamic input compression, 3 channel fast-acting output compression, 16 channel noise reduction, feedback cancellation,) bi-directional microphone with windscreen, volume and program control (environment selection - Quiet, Noisy, Concert, TV), 3 channel equalizer, self-adjustable wire and ear tips, and customization through the Braun® Clear™ Mobile Application. The Braun® ClearCheck™ Hearing Test aims to detect accurate auditory thresholds, partnering with a smart phone application to deliver user-customized sound through the Braun® Clear™ Hearing Aid. These thresholds are used to program the device using a proprietary fitting algorithm.
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K Number
K193213Device Name
Vicks VNT200 No Touch Forehead Thermometer
Manufacturer
Kaz USA, Inc., a Helen of Troy Company
Date Cleared
2020-04-28
(159 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Kaz USA, Inc., a Helen of Troy Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vicks® VNT200 No Touch Forehead Thermometer is a non-sterile, reusable, clinical thermometer intended for the intermittent determination of human body temperature in a "no touch" mode, using the center of the forehead as the measurement site, on people of all ages, in a home use environment.
Device Description
The Vicks® VNT200 No Touch Forehead Thermometer is a hand-held, battery-powered, infrared thermometer that converts a user's forehead temperature, using the infrared energy emitted in the user's forehead, to an oral equivalent temperature. It is calibrated for non-contact use at a distance of up to 5 centimeters (2 inches) from the center of the forehead. It uses an infrared thermopile sensor with integrated thermistor mounted in the head of the thermometer for the target reading and ambient temperature reading.
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K Number
K180131Device Name
Vicks RapidRead Digital Thermometer
Manufacturer
Kaz USA, Inc., A Helen of Troy Company
Date Cleared
2018-08-14
(209 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Kaz USA, Inc., A Helen of Troy Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vicks® VDT972 RapidRead™ Digital Thermometer is a handheld, battery-powered, predictive, digital stick thermometer intended for the intermittent determination of human body temperature orally, rectally, or under the arm, in a home-use environment for people of all ages (infants, children, and adults). It is intended to be used with a single-use, disposable probe cover for all measurements.
Device Description
The Vicks® VDT972 RapidRead™ Digital Thermometer is a predictive, thermistor-based, stick thermometer capable of measuring oral, axillary, or rectal temperature in 2 to 8 seconds. It is equipped with a site selection button that requires the operator to select the desired measurement site before taking a temperature. For each measurement, it must be used with a commercially-available, single-use, disposable probe cover.
The Vicks® VDT972 RapidRead™ Digital Thermometer is a contact thermometer, using a negative temperature coefficient (NTC) thermistor embedded in a measurement tip that is in contact with the measurement site. As the thermistor changes temperature, the resistance of the thermistor also changes. This change in resistance is measured by the thermometer and converted to a measurement of the temperature of the tip of the thermometer. This temperature, following the use of the predictive algorithm, is then displayed to the end user.
The Vicks® VDT972 RapidRead™ Digital Thermometer does not use a clinical offset algorithm. clinical offset algorithms are typically used to perform a measurement on one physiological site (i.e. the forehead. temple, or ear) and represent what the equivalent measurement would be at a different physiological site (i.e. oral), had the measurement been performed at that site instead. Typically, these formulas account for ambient temperature, at a minimum, in calculating the appropriate offset. Because the Vicks® VDT972 RapidRead™ Digital Thermometer displays the measurement for the physiological site at which it is used, it does not need to convert this temperature via the use of a clinical offset.
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K Number
K181242Device Name
Braun BNT400 No Touch + Forehead Thermometer
Manufacturer
Kaz USA, Inc., A Helen of Troy Company
Date Cleared
2018-07-23
(74 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Kaz USA, Inc., A Helen of Troy Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Braun BNT400 No Touch + Forehead Thermometer is a non-sterile, reusable, clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch mode using the center of the forehead as the measurement site on people of all ages.
Device Description
The Braun BNT400 No Touch + Forehead Thermometer is a hand-held, battery powered, infrared thermometer that converts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead, to an oral equivalent temperature when placed in contact with the subject's forehead or within one inch of the subject's forehead. It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.
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K Number
K181015Device Name
Braun BFH175 Infrared Forehead Thermometer
Manufacturer
Kaz USA, Inc., A Helen of Troy Company
Date Cleared
2018-07-18
(92 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Kaz USA, Inc., A Helen of Troy Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Braun BFH175 Infrared Forehead Thermometer is a non-sterile, clinical thermometer intended for the intermittent determination of human body temperature in a touch mode using the center of the forehead as the measurement site on people of all ages.
Device Description
The Braun BFH175 Infrared Forehead Thermometer is a hand-held, battery powered, infrared thermometer that converts a user's forehead temperature, using the infrared energy emitted in the user's forehead, to an oral equivalent temperature when placed in contact with the subject's forehead. It uses a thermopile sensor with integrated thermistor for the target reading and a thermistor mounted in the head of the thermometer for ambient temperature readings.
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K Number
K163516Device Name
Braun No Touch + Forehead NTF3000 Thermometer
Manufacturer
Kaz USA, Inc., a Helen of Troy Company
Date Cleared
2017-04-21
(127 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Kaz USA, Inc., a Helen of Troy Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Braun No Touch + Forehead NTF3000 Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch and no touch mode on the center of the forehead as the measurement site on people of all ages.
Device Description
The Braun No Touch + Forehead NTF3000 Thermometer is a hand-held, battery powered, infrared thermometer that converts a user's forehead temperature, using the infrared energy emitted in the area around the user's forehead, to an oral equivalent temperature when placed in contact with the subject's forehead or within two inches of the subject's forehead.
The Braun No Touch + Forehead NTF3000 Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead, and an infrared proximity sensor for detection of contact or non-contact use and compensation of the temperature reading.
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K Number
K161933Device Name
The Braun ThermoScan® 3 High Speed Compact Ear Thermometer
Manufacturer
Kaz USA, Inc., A Helen of Troy Company
Date Cleared
2016-08-16
(33 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Kaz USA, Inc., A Helen of Troy Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is intented for the intermittent measurement and monitoring of human body temperature by consumers in the home.
Device Description
The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is a hand held instrument that measures human body temperature through the opening of the auditory canal. It is a single mode ear thermometer that measures the natural thermal infrared radiation emitted from the tympanic membrane and adjacent surfaces. The Braun ThermoScan® 3 High Speed Compact Ear Thermometer is meant for intermittent measurement and monitoring of human body temperature by consumers of all ages in a home use environment.
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K Number
K152975Device Name
VDT985US Vicks SmartTemp Thermometer
Manufacturer
Kaz USA, Inc., a Helen of Troy Company
Date Cleared
2016-03-23
(167 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Kaz USA, Inc., a Helen of Troy Company
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The VDT985US Vicks® SmartTemp™ Thermometer is indicated for the intermittent measurement and monitoring of human body temperature orally, rectally or under the arm. It can be used on people of all ages except preterm babies or very small (for gestational age). This thermometer is intended to be used with Apple and Android mobile devices. It is intended for household use only.
Device Description
The VDT985US Vicks® SmartTemp™ Thermometer is a general purpose thermometer. The thermometer is intended for oral, axillary temperature measurements of the human body. The main user interface for the thermometer is a smartphone or other Bluetooth smart device on which the Kaz SmartTemp app is installed. The thermometer communicates with the user's device through a Bluetooth smart connection.
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