(201 days)
Not Found
No
The description relies on Bioelectrical Impedance Analysis (BIA) and a previously approved methodology, with no mention of AI or ML terms or concepts.
No
The device is a body composition analyzer that measures body weight and estimates body fat, not a device intended to treat or cure a disease or condition.
No.
The device measures body weight and body composition parameters like body fat percentage, BMI, and basal metabolic rate. While these measurements provide health-related information, they do not diagnose a disease or condition, but rather provide data points for general health assessment.
No
The device description explicitly states it consists of a platform scale with electrodes, which are hardware components used to measure body weight and impedance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure body weight and estimate body composition parameters like body fat percent, BMI, fat mass, etc., using BIA. This is a measurement of physical characteristics of the body, not an analysis of biological samples (like blood, urine, tissue) to diagnose or monitor a disease or condition.
- Device Description: The device measures impedance and body weight by having the user stand on a scale with footpad electrodes. This is a physical measurement, not an in vitro test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device measures physical attributes of the body directly.
N/A
Intended Use / Indications for Use
Intended to be used as a body fat analyzer that determines body weight and estimates body fat composition with the use of BIA (bioelectrical impedance analysis).
MODELS TBF-300A, TBF-310, TBF-410, TBF-215, BF-350:
A body composition analyzer that measures body weight and impedance and estimates body fat percent. BMI, fat mass, fat free mass, basal metabolic rate, and total body water using BIA (bioelectrical impedance analysis).
MODELS TBF-611, TBF-612, TBF-621, TBF-622, BF-623, BF-625, BF-626, BF-541, BF-555, BF-542, TBF-551, BF-556, BF-558, BF-559, BF-572, TBF-521, Ultimate Scale 2001:
A body composition analyzer that measures body weight and impedance and estimates body fat percent using BIA (bioelectrical impedance analysis).
Product codes
74 MNW
Device Description
The TANITA Body Fat Monitor/Scales (multiple models) are designed to determine body weight and body fat composition. Each model will offer a range of features. The system consists of two subdivided stainless steel footpad electrodes mounted on a platform scale. The four-foot electrodes are designed where each foot makes contact with a heel and toe electrode. Impedance of the lower extremities and body weight is measured simultaneously while the subject stands on the scale.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Side by side comparisons of the TANITA Body Fat Analyzer TBF/ BF/ Ultimate Scale to the predicate device Body Fat Analyzer Model TBF-105 clearly demonstrate that the applicant device is substantially equivalent to the legally marketed device.
Based on the results of using the previously approved "Foot-to-Foot" BIA methodology with our patented in-house BIA it was concluded that the TANITA Body Fat Analyzer(s) TBF/BF/Ultimate Scales perform as well as the predicate device and therefore have proven its safety and efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2770 Impedance plethysmograph.
(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
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SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92
| Trade Name: | TANITA Body Fat Analyzer TBF/BF/ Ultimate Scale |
|---|---|
| Common Name: | Body Fat Analyzer/ Body Fat Monitors/ Body Composition Analyzers/ |
| Body Composition Monitors | |
| Classification Name: | ANALYZER, BODY COMPOSITION |
| 21 CFR § 870.2770 |
Description of Applicant Device:
The TANITA Body Fat Monitor/Scales (multiple models) are designed to determine body weight and body fat composition. Each model will offer a range of features. The system consists of two subdivided stainless steel footpad electrodes mounted on a platform scale. The four-foot electrodes are designed where each foot makes contact with a heel and toe electrode. Impedance of the lower extremities and body weight is measured simultaneously while the subject stands on the scale.
Intended Uses of Applicant Device:
Intended to be used as a body fat analyzer that determines body weight and estimates body fat composition with the use of BIA (bioelectrical impedance analysis).
Predicate Device:
TANITA Body Fat Analyzer Model TBF-105 K930599
Scientific Concepts and Significant Performance Characteristics:
| | Body Fat Analyzer Model TBF-
105
K930599 | TANITA Body Fat Analyzer
TBF/BF/ Ultimate Scale |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE: | A combination non-invasive
device, which determines weight
and estimates body fat
composition using BIA
(bioelectrical impedance
analysis). | A combination non-invasive
device, which determines weight
and estimates body fat
composition using BIA
(bioelectrical impedance
analysis). |
| PRODUCT DESCRIPTION: | Body composition analyzer/scales
utilize a “foot-to-foot” BIA (bio-
electrical impedance) technology -
to determine internal body
composition. | Body composition analyzer/scales
utilize a “foot-to-foot” BIA (bio-
electrical impedance) technology
to determine internal body
composition. |
| ANALYTICAL
METHOD/MEASUREMENT | • “Foot-to-Foot” BIA
• Patented in-house BIA and
DEXA reference methods | • “Foot-to-Foot” BIA
• Patented in-house BIA and
DEXA reference methods |
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510(k) SUMMARY, continued
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92
Side by side comparisons of the TANITA Body Fat Analyzer TBF/ BF/ Ultimate Scale to the predicate device Body Fat Analyzer Model TBF-105 clearly demonstrate that the applicant device is substantially equivalent to the legally marketed device.
Based on the results of using the previously approved "Foot-to-Foot" BIA methodology with our patented in-house BIA it was concluded that the TANITA Body Fat Analyzer(s) TBF/BF/Ultimate Scales perform as well as the predicate device and therefore have proven its safety and efficacy.
Carol Alloian (Benson) TANITA Corporation of America Manager Requiatory Affairs Manager Phone: (847) 640-9251 ext. 116 (847) 640-7978 Fax:
November 30, 2001
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Public Health Service
Image /page/2/Picture/2 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name around the perimeter of the circle. Inside the circle is a stylized emblem with three wave-like shapes.
JUN 2 4 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Carol Alloian (Benson) Regulatory Affairs Manager TANITA Corporation of America 2625 South Clearbrook Drive ARLINGTON HEIGHTS IL 60005 Re: K014009 Trade/Device Name: Body Fat Analyzer, Professional Series: Models TBF-300A. TBF-310. TBF-410, TBF-215, and BF-350; Consumer Body Fat Monitor/Scale Series: Models TBF-611, TBF-612, TBF-621, TBF-622, BF-623, BF-625, BF-626, BF-541, BF-555, BF-542, TBF-551, BF-556, BF-558, BF-559, BF-572, TBF-521 Ultimate Scales 2000, 2001, and 2001T Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: March 25, 2002 Received: March 26, 2002
Dear Ms. Alloian:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Part 801): good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C.Bogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K014009 510(k) Number (if known):
Tanita Body Fat Analyzer Device Name:
Indications for Use:
MODELS TBF-300A, TBF-310, TBF-410, TBF-215, BF-350:
A body composition analyzer that measures body weight and impedance and estimates body fat percent. BMI, fat mass, fat free mass, basal metabolic rate, and total body water using BIA (bioelectrical impedance analysis).
MODELS TBF-611, TBF-612, TBF-621, TBF-622, BF-623, BF-625, BF-626, BF-541, BF-555, BF-542, TBF-551, BF-556, BF-558, BF-559, BF-572, TBF-521, Ultimate Scale 2001:
A body composition analyzer that measures body weight and impedance and estimates body fat percent using BIA (bioelectrical impedance analysis).
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-the-Counter Use ✓ |
| (Optional Format 1-2-96) |
(Division Sign-Off)
Division of Reproductive, Abdominal,
Revised: 6/24/02
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