HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960

K030349 · Bonso Electronics International, Inc. · MNW · May 2, 2003 · Cardiovascular

Device Facts

• Record ID: K030349
• Device Name: HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960
• Applicant: Bonso Electronics International, Inc.
• Product Code: MNW · Cardiovascular
• Decision Date: May 2, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

The Bonso Electronics Int'l., Inc., Healthometer Professional Body Fat Monitor and Scale Models BFM 940, BFM 945, and BFM 960 are indicated to measure body weight and impedance and estimate body fat percent.

Device Story

Portable body fat monitor and scale; measures body weight via internal strain gauges; measures body impedance; estimates body fat percentage. Used by human subjects standing on platform. Healthcare providers or users view output on device display to monitor body composition. Benefits include tracking weight and body fat metrics.

Clinical Evidence

Bench testing only; comparative testing performed against predicate device.

Technological Characteristics

Platform-type weighing scale; internal strain gauges for weight measurement; bioelectrical impedance analysis (BIA) for body fat estimation. Portable form factor.

Indications for Use

Indicated for human subjects to measure body weight and impedance and estimate body fat percentage.

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.

Predicate Devices

• Tanita BF-625/BF-626 (K014009)

Submission Summary (Full Text)

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MAY - 2 2003

## PREMARKET NOTIFICATION 510(K) SUMMARY 8.0

| Sponsor | Bonso Electronics International Inc. |
|----------------|--------------------------------------|
| | 1919 Yacht Colnia |
| | Newport Beach CA 92660 |
| Contact Person | Mr. George O'Leary, Director |
| Phone | 949-760-7611 |
| Fax | 949-760-7607 |
| Email | [e-mail] |

Device Name

| Trade Name of Device | Healthometer Professional Body Fat Monitor and Scale |
|----------------------|------------------------------------------------------|
| | (Models BFM940, BFM945, and BFM960) |
| Common Name | Body Fat Analyzer |
| Classification name | Analyzer, Body Composition |
| Product Code | MNW |
| Regulation Class | Class II |
| Regulation Number | §870.2770 |

Indications for Use

The Healthometer Professional Body Fat Monitor and Scale is indicated to measure body weight and impedance and estimate body fat percent.

## Device Description

-

--

The Bonso BFM is a portable device for measuring the percentage of body fat in human subjects. The device includes a platform-type weighing scale that utilizes internal strain gauges to electronically measure the weight of a subject standing on the scale platform.

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## Basis for Substantial Equivalence

| Predicate Device | Tanita BF-625/BF-626 |
|------------------|---------------------------------------------------------------------------------------|
| 510(k) # | K014009 |
| Sponsor | Tanita Corp. of America<br>2625 South Clearbrook Drive<br>Arlington Heights, IL 60005 |

The 510(k) contains extensive bench data demonstrating that the Bonso device performs as labeled. Additionally, testing directly comparing the Bonso and the predicate device was provided. This testing showed that the Healthometer Professional Body Fat Monitor and Scale is substantially equivalent to the Tanita BF-625/BF-626 that is also indicated for use to measure body weight and impedance and estimate body fat percent using the BIA method.

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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three lines representing its wings and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY - 2 2003

Bonso Electronics Int'l., Inc. c/o Russell P. Pagano, Ph.D. Vice President M Squared Associates, Inc. 719 A Street, N.E. WASHINGTON DC 20002

Re: K030349

Trade/Device Name: Healthometer Professional Body Fat Monitor and Scale Models BFM 940, BFM 945, and BFM 960 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: January 31, 2003 Received: February 3, 2003

Dear Dr. Pagano:

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, listing 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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on vour responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy Cbrogdon

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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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):_ K030349

Device Name: The Healthometer Professional Body Fat Monitor and Scale Models BFM 940, BFM 945, and BFM 960

Indications For Use: The Bonso Electronics Int'l., Inc., Healthometer Professional Body Fat Monitor and Scale Models BFM 940, BFM 945, and BFM 960 are indicated to measure body weight and impedance and estimate body fat percent.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Samuel Mhando Sda NB

Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number

(Optional Format 3-10-98)

Over-the-Counter Use.