(98 days)
Not Found
No
The summary describes a device using Bioelectrical Impedance Analysis (BIA) and does not mention AI, ML, or any related concepts.
No.
The device is a body composition analyzer that measures body fat and water percentage, which is for diagnostic/monitoring purposes, not therapeutic.
No
The device measures body weight, impedance, and estimates body fat and water percentage. While it provides data, it does not diagnose a disease, condition, or state of health directly; it provides measurements that can be used for general health monitoring or by healthcare professionals as part of a broader diagnostic process, but the device itself is not presented as making a diagnosis.
No
The device description explicitly states it is a "computer-operated body composition analyzer" and utilizes BIA, which requires hardware (electrodes, circuitry) to measure impedance. The summary also refers to a "TANITA Scale," indicating a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases, conditions, or infections.
- Device Function: The device described measures body weight and impedance using BIA to estimate body composition (fat and water percentage). This is done by applying a small electrical current to the body and measuring the resistance. This process is performed on the body, not on a sample taken from the body.
- Intended Use: The intended use is for estimating body composition in healthy individuals, not for diagnosing diseases or conditions based on analysis of biological samples.
Therefore, the device falls under the category of a general wellness or body composition analysis device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
A body composition analyzer that measures body weight and impedance and estimates percentage of body fat and body water using BIA (bioelectrical impedance analysis) in healthy children (7-17 years old) and healthy adults.
Product codes
74 MNW
Device Description
The TANITA Scale plus Body Fat Monitor with Body Water Percentage is a computeroperated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat and body water percentage.
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
healthy children (7-17 years old) and healthy adults
Intended User / Care Setting
Not Found
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
No new tests were performed apart from the validation of the new total body water algorithm. 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 Scale plus Body Fat Monitor with Body Water Percentage performs as well as the predicate devices.
Key Metrics
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.
0
TANITA Scale plus Body Fat Monitor with Body Water Percentage 510(k) Submission
JUL 2 2 2004
510(k) SUMMARY
This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92
| Trade Name: | TANITA Scale plus Body Fat Monitor with Body Water Percentage
Models BF-592 and UM-026 |
|-------------------------|-------------------------------------------------------------------------------------------|
| Common Name: | Body Composition Analyzer / Body Fat Analyzer / Body Fat Monitor |
| Classification
Name: | ANALYZER, BODY COMPOSITION
21 CFR § 870.2770 |
Description of Applicant Device:
The TANITA Scale plus Body Fat Monitor with Body Water Percentage is a computeroperated body composition analyzer that utilizes BIA (bioelectrical impedance analysis) to determine body fat and body water percentage.
Intended Uses of Applicant Device:
Intended to be used as a body fat analyzer that determines body weight and estimates body fat and total body water with the use of BIA (bioelectrical impedance analysis).
Predicate Devices:
TANITA Body Fat Analyzer Professional and Consumer Models K014009
Scientific Concepts and Significant Performance Characteristics:
| | Tanita Body Composition
Analyzer
Professional Models
K014009 | Tanita Body
Composition Analyzer
Consumer Models
K014009 | Tanita Scale plus Body
Fat Monitor with Body
Water Percentage
Multiple Models |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INTENDED USE: | A combination non-
invasive device, which
determines weight and
estimates body fat and
total body water using
BIA (bioelectrical
impedance analysis). | A combination non-
invasive device, which
determines weight and
estimates body fat using
BIA (bioelectrical
impedance analysis). | A combination non-
invasive device, which
determines weight and
estimates body fat and
total body water using
BIA (bioelectrical
impedance analysis). |
| PRODUCT
DESCRIPTION: | Body composition
analyzer/scale that
utilizes a "foot-to-foot" BIA
(bioelectrical impedance)
technology to determine
internal body
composition. | Body composition
analyzer/scale that
utilizes a "foot-to-foot"
BIA (bioelectrical
impedance) technology
to determine internal
body composition. | Body composition
analyzer/scale that
utilizes a "foot-to-foot"
BIA (bioelectrical
impedance) technology
to determine internal
body composition. |
| ANALYTICAL
METHOD/
MEASUREMENT | Foot-to-Foot BIA In-house BIA and
DEXA reference
methods | Foot-to-Foot BIA In-house BIA and
DEXA reference
methods | Foot-to-Foot BIA In-house BIA and
DEXA/Deuterium
Dilution reference
methods |
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KC4i978
PAGE 2 OF 2
TANITA Scale plus Body Fat Monitor with Body Water Percentage 510(k) Submission
510(k) SUMMARY, continued
This summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92
Side by side comparison of the TANITA Scale plus Body Fat Monitor with Body Water Percentage to the predicate devices clearly demonstrates that the applicant device is substantially equivalent to the legally marketed devices. No new tests were performed apart from the validation of the new total body water algorithm.
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 Scale plus Body Fat Monitor with Body Water Percentage performs as well as the predicate devices.
Rhoda Lynn Valera TANITA Corporation of America Requlatory Affairs Specialist
2625 S. Clearbrook Dr. Arlington Heights, IL 60005 Phone: (847) 434-3966 (847) 640-7978 Fax:
July 15, 2004
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Image /page/2/Picture/1 description: The image shows a logo with a circular border containing text, surrounding a stylized graphic of three curved lines resembling birds in flight. The text is arranged along the circumference of the circle. The logo appears to be a symbol for an organization or company, with the bird-like figures possibly representing freedom, movement, or environmental themes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 2 2004
TANITA Corporation of America c/o Ms. Chantel Carson Mgr. Section 1 Underwriters Laboratories, Inc. Northbrook Division 333 Pfingsten Road NORTHBROOK IL 60062-2096
Re: K040978
Trade/Device Name: Tanita Scale plus Body Fat Monitor with body Water Percentage Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: July 6, 2004 Received: July 7, 2004
Dear Ms. Carson:
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 for ass stated in the encreations of the enactment date of the Medical Device Amendments, or to oonimores provision of they 2011 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 r ou may , ater s , servisions of the Act include requirements for annual registration, listing of general volurole provision 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 r that FDA has made a determination that your device complies with other requirements of the Act that + Drederal 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 rord in the quality afferents (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will anow you to ocgin martes.ing your antial equivalence of your device to a legally premarket notheation. The PDA misms of easing 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 If you destre specific advice for your do too of the following numbers, based on the regulation number at the top of the 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 Additionally, 101 questions on the promote the regulation entitled, "Misbranding Onlice of Complance at (501) 97 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 - 100 by relevelice to premarked nonitous on the Act may be obtained from the Division of Small information on your responsion and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Octaess http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
TANITA Scale plus Body Fat Monitor with Body Water Percentage 510(k) Submission
INDICATIONS FOR USE
| 510(k) Number: | K040978 |
|---|---|
| Device Name: | TANITA Scale plus Body Fat Monitor with Body Water |
| Percentage Models BF-592 and UM-026 | |
| Indications for Use: | A body composition analyzer that measures body weight and |
| impedance and estimates percentage of body fat and body | |
| water using BIA (bioelectrical impedance analysis) in healthy | |
| children (7-17 years old) and healthy adults. |
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy c Brogdon
(Division Sign-Off)/ Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _