OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400

K043060 · Omron Healthcare, Inc. · MNW · Jan 19, 2005 · Cardiovascular

Device Facts

• Record ID: K043060
• Device Name: OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400
• Applicant: Omron Healthcare, Inc.
• Product Code: MNW · Cardiovascular
• Decision Date: Jan 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device is a non-invasive bio-impedance analyzer with scale for use in estimating human's body fat percentage by calculation using the individual's BMI (body mass index) and determination of body weight. The OMRON HBF-400 is intended to be used by healthy individuals between the age of 10 to 80 years.

Device Story

The OMRON HBF-400 is a non-invasive bio-impedance analyzer combined with a weight scale. It is designed for over-the-counter use by healthy individuals. The device measures body weight and uses bio-impedance technology, in conjunction with the user's BMI, to estimate body fat percentage. The user interacts with the device by standing on the scale; the device processes the electrical impedance data and weight to provide a body fat percentage output. This information is intended for personal health monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bio-impedance analyzer and weight scale. Operates via bio-electrical impedance analysis. Intended for over-the-counter use. Class II device under 21 CFR 870.2770 (Product Code: MNW).

Indications for Use

Indicated for healthy individuals aged 10 to 80 years for the estimation of body fat percentage and measurement of body weight.

Regulatory Classification

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.

Special Controls

*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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of protecting the health of all Americans and providing essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2005

Mr. Larry Lepley Manager, Regulatory/Clinical Affairs OMRON Healthcare, Inc. 1200 Lakeside Drive BANNOCKBURN IL 60015-1243

Re: K043060

Trade/Device Name: OMRON Model HBF-400 Fat Loss Monitor and Scale Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: November 5, 2004 Received: November 15, 2004

Dear Mr. Lepley:

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 Section 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:

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.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

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## Indications for Use

510(k) Number (if known): Ko 430 GO

OMRON Model HBF-400 Fat Loss Monitor and Scale Device Name:

The device is a non-invasive bio-impedance analyzer Indications For Use: with scale for use in estimating human's body fat percentage by calculation using the individual's BMI (body mass index) and determination of body weight. The OMRON HBF-400 is intended to be used by healthy individuals between the age of 10 to 80 years.

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 IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dorint A. Legmm

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devi

510(k) Number