TANITA SCALE PLUS BODY FAT MONITOR WITH BODY WATER PERCENTAGE

{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<br>Models BF-592 and UM-026 | |-------------------------|-------------------------------------------------------------------------------------------| | Common Name: | Body Composition Analyzer / Body Fat Analyzer / Body Fat Monitor | | Classification<br>Name: | ANALYZER, BODY COMPOSITION<br>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<br>Analyzer<br>Professional Models<br>K014009 | Tanita Body<br>Composition Analyzer<br>Consumer Models<br>K014009 | Tanita Scale plus Body<br>Fat Monitor with Body<br>Water Percentage<br>Multiple Models | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | INTENDED USE: | A combination non-<br>invasive device, which<br>determines weight and<br>estimates body fat and<br>total body water using<br>BIA (bioelectrical<br>impedance analysis). | A combination non-<br>invasive device, which<br>determines weight and<br>estimates body fat using<br>BIA (bioelectrical<br>impedance analysis). | A combination non-<br>invasive device, which<br>determines weight and<br>estimates body fat and<br>total body water using<br>BIA (bioelectrical<br>impedance analysis). | | PRODUCT<br>DESCRIPTION: | Body composition<br>analyzer/scale that<br>utilizes a "foot-to-foot" BIA<br>(bioelectrical impedance)<br>technology to determine<br>internal body<br>composition. | Body composition<br>analyzer/scale that<br>utilizes a "foot-to-foot"<br>BIA (bioelectrical<br>impedance) technology<br>to determine internal<br>body composition. | Body composition<br>analyzer/scale that<br>utilizes a "foot-to-foot"<br>BIA (bioelectrical<br>impedance) technology<br>to determine internal<br>body composition. | | ANALYTICAL<br>METHOD/<br>MEASUREMENT | Foot-to-Foot BIA In-house BIA and<br>DEXA reference<br>methods | Foot-to-Foot BIA In-house BIA and<br>DEXA reference<br>methods | Foot-to-Foot BIA In-house BIA and<br>DEXA/Deuterium<br>Dilution reference<br>methods | 2 {1}------------------------------------------------ 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 {2}------------------------------------------------ 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<br>Percentage Models BF-592 and UM-026 | | Indications for Use: | A body composition analyzer that measures body weight and<br>impedance and estimates percentage of body fat and body<br>water using BIA (bioelectrical impedance analysis) in healthy<br>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 _