HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX

K031167 · Idt Technology Limited · MNW · Jan 28, 2004 · Cardiovascular

Device Facts

• Record ID: K031167
• Device Name: HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX
• Applicant: Idt Technology Limited
• Product Code: MNW · Cardiovascular
• Decision Date: Jan 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel. The intended use of this device is for 7 to 99 years old normal subjects and not for I he intended use of ans econmended personal with implanted internal device like pacemaker or pregnant women to use this device.

Device Story

Oregon Scientific High Precision Body Weight Monitor (Model GA101) is a consumer-use device for body composition monitoring. It utilizes bioelectrical impedance analysis (BIA) to measure body weight and impedance; calculates body fat percentage and BMI. Results are displayed on an integrated LCD panel. Intended for home use by healthy individuals aged 7-99. Device operation involves standing on the scale; electrical signals pass through the body to estimate composition. Provides users with weight and body composition metrics to track health status. Contraindicated for users with pacemakers or pregnancy due to electrical current flow.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Impedance plethysmograph; utilizes bioelectrical impedance analysis (BIA) for body composition estimation. Features integrated LCD display for output. Powered by internal batteries. Designed for consumer/home use.

Indications for Use

Indicated for normal subjects aged 7 to 99 years to measure body weight, body fat percentage, and BMI. Contraindicated for pregnant women and individuals with implanted internal medical devices such as pacemakers.

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 features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The caduceus is a symbol of medicine and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JAN 2 8 2004

Mr. Stephen Li Vice President - Health Care Products IDT Technology Limited Block C, 9/F., Kaiser Estate Phase 1, 41 Man Yue Street Hunghom, Hong Kong, CHINA

Re: K031167

Trade/Device Name: Oregon Scientific High Precision Body Weight Monitor with Body Fat Index, Model GA101 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: December 1, 2003 Received: December 10, 2003

Dear Dr. Li:

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 answer a may 28, 1976, the enactment date of the Medical Device Amendments, or to oonimer of the rest to rial 2011 de noos that have been 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 I ou may, ato.es or visions 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 r tease be as 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 or any 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) This letter will allow you to begin marketing for articlequivalence of your device to a legally premarket notification. The FDA inting or saccuman equivalias 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 desire specific advice for your device on our line following numbers, based on the regulation number at the top of the 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 Additionally, for questions on the promotion and and one the regulation entitled, "Mistranding Office of Compliance at [phone]. This, processor. The Division of Small by reference to premarket notification (21 CF CF Cr In C From the Division of Staall
information on your responsibilities under the Act the first from the [phone] information on your responsibilities under Assistance at its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-free decreenc Manufacturers, International and Collsums: 126.0001.10.10.2007/00/01/dsma/dsmamain.html.
[phone] or at its Internet address http://www.fda.gov/cdrh/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

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510(k) Number (if known): 5031167

Device Name: Oregon Scientific High Precision Body Weight Monitor with Body Fat Index Model: GA101

Indications for Use:

The device measures body weight, and impedance using Bioelectrical Impedance The uevice measures body worgin, and cally fat percentage, BMI, with results displayed in LCD panel.

The intended use of this device is for 7 to 99 years old normal subjects and not for I he intended use of ans econmended personal with implanted internal device like pacemaker or pregnant women to use this device.

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

Concurence of CDRH, Office of Device Evaulation (ODE)

Prescription Use______________________________________________________________________________________________________________________________________________________________

OR

Over-the-Counter Use

David K. Lyonn

(Optional Format 3-10-98)

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K031167