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510(k) Data Aggregation
K Number
K231116Device Name
Multi-parameter detector
Manufacturer
Zhongshan Jinli Electronic Weighing Equipment Co., Ltd.
Date Cleared
2024-06-15
(422 days)
Product Code
MNW, DQA, DXN, FLL
Regulation Number
870.2770Why did this record match?
Product Code :
MNW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Multi-parameter detector is intended to be used for measuring and displaying of non-invasive blood pressure (NBP). non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), weight and height in adults.
The Multi-parameter detector is also intended to estimate body mass index (BMI), Body fat percentage, basal metabolism and free fat mass, bone mass and body water percentage) using the BIA (Bio-electrical Impedance Analysis) method.
Device Description
The Multi-parameter detector is a device designed for measuring of the patient's physiological parameters. The Multi-parameter detector can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressure (NIBP, the pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology.
The Multi-parameter detector are non-invasive body composition analyzers. The devices employ BIA (Bio-electrical Impedance Analysis) method and then measure body composition using an experimentally derived algorithm.
The Multi-parameter detector integrates an FDA market cleared devices, All-in-One Health Monitor (K170047) for measurement of oxygen saturation of arterial hemoqlobin (SpO2).
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K Number
K140045Device Name
BODY COMPOSITION ANALYZER
Manufacturer
JAWON MEDICAL CO., LTD.
Date Cleared
2015-02-18
(406 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Product Code :
MNW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
These devices calculates and estimates body composition parameters by using measured weight and impedance and entered height, age and gender. It shows body composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, Goal setter.
In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).
These devices can only estimate the body composition parameters with the exception of Weight, BMI, and impedance. These devices are only for use with generally healthy individuals of a specified age range.
Device Description
These devices calculates and estimates body composition parameters by using measured weight and impedance and entered height, age and gender. It shows body composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, Goal setter.
In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).
These devices can only estimate the body composition parameters with the exception of Weight, BMI, and impedance. These devices are only for use with generally healthy individuals of a specified age range.
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K Number
K141483Device Name
BIOSPACE BODY COMPOSITION ANALYZER
Manufacturer
BIOSPACE CORPORATION LIMITED
Date Cleared
2014-09-23
(110 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Product Code :
MNW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use only in healthy subjects for Measurement of:
Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ICW), Total Body Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Shape Graph, Weight Control, Fat Control, Muscle Control, Segmental ECW/TBW, Segmental ICW, TBW/LBM, Leg Lean Mass, Fitness Score, AC (Arm Circumference)
Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for InBody S10], Reactance Values [only for InBody770, InBody S10], Phase Angle [only for InBody770, InBody S10]
Device Description
Impedance plethysmographic devices are used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. Multi-frequency and segmental bioelectrical impedance analysis can estimate the distribution of body water (total body water; intra-cellular water), and can correlate with fluid compartmentalization. Assuming that body lean mass is hydrated in a constant and uniform manner; bioelectrical impedance analysis can be used to estimate body lean mass and fat mass.
These devices are impedance plethysmograph body composition analyzers. These devices determine body composition parameters based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both resistance and capacitance components. Impedance plethysmographic devices are used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. Multi-frequency and segmental bioelectrical impedance analysis can estimate the distribution of body water (total body water; intra-cellular water; extra-cellular water), and can correlate with fluid compartmentalization. Assuming that body lean mass is hydrated in a constant and uniform manner; bioelectrical impedance analysis can be used to estimate body lean mass and fat mass. Body composition analysis results may be of value to health care professionals in their management of the relative balance and levels of fat and lean tissue
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K Number
K133872Device Name
ARIA WIFI SMART SCALE
Manufacturer
FITBIT, INC.
Date Cleared
2014-06-02
(164 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Product Code :
MNW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ARIA WiFi Smart Scale is a body analyzer that measures body weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat percentage in generally healthy individuals 10 years of age or older. It is intended for home use only.
Device Description
ARIA is a body weight scale and a body fat analyzer that operates by using a low, safe, battery-generated electrical current through the body (using a bioelectrical impedance analysis technique) to provide body fat and body weight information. After the user registers their scale, the scale automatically recognizes the subject based on body weight and body fat readings. ARIA contains a WiFi module (802.11 module) that allows it to connect to the Internet in the user's home. The module provides a complementary interface to the Fitbit website. Body weight and body fat measurements are independent of internet communication after initial product registration.
The ARIA scale automatically measures body weight and body fat composition. The scale recognizes the user based on previous weight readings, and can accept up to eight (8) different users. The 16 most recent readings are kept in memory on the scale and readings are also transmitted to the user's optional fitbit.com personal account for trending. If users have similar weight, the proper identity can be selected by tapping the scale.
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K Number
K140594Device Name
BODY FAT ANALYZER AND SCALE
Manufacturer
CONMO ELECTRONIC COMPANY LIMITED
Date Cleared
2014-05-30
(84 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Product Code :
MNW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Body Fat Analyzer and Scale measures body weight and impedance and estimates percentage of body fat, body water and body muscle mass using BIA (bioelectrical impedance analysis). It is intended for use by healthy adults 18 years of age or older who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy for body composition assessment in the home environment.
Device Description
The patient steps on the scale device, where four electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Conmo Electronic Company Limited Body Fat Analyzer and Scale provides weight, calculates the body fat, body water and body muscle mass. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance, height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.
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K Number
K130777Device Name
INBODY
Manufacturer
BIOSPACE CORPORATION LIMITED
Date Cleared
2013-11-25
(249 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Product Code :
MNW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use only in healthy subjects for Measurement of:
Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental · Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Water, Body Shape Graph, Weight Control, Fat Control, Muscle Control
Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for InBody720], Reactance Values [only for InBody720], Phase Angle fonly for InBody720]
Device Description
These devices are impedance plethysmograph body composition analyzers. These devices determine body composition parameters based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both resistance and capacitance components. Impedance plethysmographic devices are used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. Multi-frequency and segmental bioelectrical impedance analysis can estimate the distribution of body water (total body water; intra-cellular water), and can correlate with fluid compartmentalization. Assuming that body lean mass is hydrated in a constant and uniform manner; bioelectrical impedance analysis can be used to estimate body lean mass and fat mass. Body composition analysis results may be of value to health care professionals in their management of the relative balance and levels of fat and lean tissue
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K Number
K130856Device Name
BIA / VITALITY ANALYZER
Manufacturer
IPGDX, LLC
Date Cleared
2013-11-25
(242 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Product Code :
MNW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BIA/Vitality Analyzer™ is indicated for "generally healthy" subjects of 18 to 87 years old. The BlA/Vitality Analyzer™ is intended to estimate a person's body composition parameters of Fat Free Mass, Fat Mass, Total Body Water and Extra-Cellular Water.
Device Description
Not Found
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K Number
K130952Device Name
PRECISION ONE LIFECARE; DETECTO; DETECTO
Manufacturer
PRECISION ONE LIFECARE, LTD.
Date Cleared
2013-09-26
(174 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Product Code :
MNW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Precision One Lifecare and Detecto Body Fat scales measure weight and use bioelectrical impedance analysis (BIA) technology to estimate and keep a record of body fat percent, total body water percent, bone mass percent, and muscle mass percent. The scales also provide a daily calorie intake recommendation and a fitness assessment. The scales are intended for use in the home/domestic setting only.
Estimated body fat percent is intended for use on individuals 7-17 years old (Healthy Children) and 18-80 years old (Healthy Adults).
Estimated body water percent, estimated muscle mass percent, estimated bone mass percent, and calorie intake are intended for use on individuals 18-80 years old.
Children under 7 years old and adults over 80 years old can use the scales for normal weighing mode only.
The scales are not intended for diagnosis.
Device Description
The Body Fat scales use BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat percent, muscle percent, body water percent, and bone percent. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer.
The devices are single frequency electrical bio-impedance analyzer. All models measure current, voltage and phase angle, calculate impedance, resistance and reactance. These measurements and calculations are used to estimate the body composition of: body fat percent, body water percent, muscle mass percent, bone mass percent, daily calories intake recommendation, and provides a fitness assessment. All models have a bi-polar set of contact electrodes which are attached to stainless steel pads on the platform of the analyzer.
The scales can store the personal data of up to 12 users. As well as being an analyzer, these devices can be used as a conventional scale. The models have one operating mode: Algorithm Mode.
Algorithm Mode; Displays estimates of body fat percent and body water percent. The devices compute these values using accepted reviewed published algorithms tailored to the candidate types: general population of the accepted age ranges of adult or children.
The devices consist of a main unit having a glass or stainless steel platform for the user to step on. On the platform, 2 stainless steel electrodes are mounted which are connected to the electronics circuitry with the analyzing MCU. When the user steps on the electrodes (1 for each foot) a small current of about 90μA will pass through the user body through the 2 feet to complete the close circuitry in order for the analyzer to measure and capture the electrical data change in terms of Bio electrical impedance, resistance, reactance, taking into account other parameters as to personal data of Age, Height, Gender, and Weight.
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K Number
K131394Device Name
TRANSTEK GLASS BODY FAT ANALYZER
Manufacturer
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Date Cleared
2013-09-18
(126 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Product Code :
MNW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Transtek Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older.
It is intended for use in the home/domestic setting only.
Device Description
Transtek Glass Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water, muscle mass and bone mass. The electrical current is low and may not be felt. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'Bioelectrical Impedance', and is accurately measured by Glass Body Fat Analyzer LS203-B.
This method simultaneously calculates your personal weight, body fat, total body water, muscle mass and bone mass, giving you a more accurate reading of your overall health and fitness.
Transtek Glass Body Fat Analyzer GLS203-B embeds a Bluetooth module that allows it to connect to nearby BT receiving terminal. Once measurement is over, the LCD of device displays measurement results, and the device will start to send out measurement data to paired BT terminal at the same time. Thus users can receive, display, and storage measurement results from LS203-B unit through mobile BT terminal.
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K Number
K130311Device Name
TRANSTEK BODY FAT ANALYZER
Manufacturer
GUANGDONG TRANSTEK MEDICAL ELECTRONICS CO., LTD
Date Cleared
2013-05-30
(111 days)
Product Code
MNW
Regulation Number
870.2770Why did this record match?
Product Code :
MNW
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Transtek Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older.
It is intended for use in the home/domestic setting only.
Device Description
Transtek Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body far mass, total body water, muscle mass and bone mass. The electrical current is low and may not be felt. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'Bioelectrical Impedance', and is accurately measured by Transtek Body Fat Analyzer (GBF-1251-B, BF-1256-B, and GBF-1257-B).
This method simultaneously calculates personal body water, muscle mass, and bone mass, giving a more accurate reading of overall health and fitness. As well as being an analyzer, this device can be used as a conventional weight scale.
The Transtek Body Fat Analyzer embeds a Bluetooth (BT) module that allows it to connect to nearby BT receiving end. The LCD of device displays results. And once measurement is over, the device will start transmission data by BT. Thus users can receive, and display/storage, measurement data of Transtek Body Fat Analyzer unit through their end devices that embedded BT module.
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