DUTECK BODY COMPOSITION ANALYZER

K060642 · Duteck Industrial Co., Ltd. · MNW · Jun 7, 2006 · Cardiovascular

Device Facts

• Record ID: K060642
• Device Name: DUTECK BODY COMPOSITION ANALYZER
• Applicant: Duteck Industrial Co., Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: Jun 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzer, measure body weight and impedance and estimates body non-invasive, of body fat, body water and skeletal muscle mass by using BIA method (bioelectrical impedance analysis). They are intended to use by healthy people age 10 to 80, (offective lifestyles for body composition assessment in the home environment.

Device Story

The DUTECK (MicHealth) Body Composition Analyzer is a stand-on, non-invasive device used in home environments by healthy individuals. It measures body weight and electrical impedance using the bioelectrical impedance analysis (BIA) method. The device processes these inputs to estimate body fat, body water, and skeletal muscle mass. Users stand on the device to obtain measurements, which are then displayed to the user to assist in monitoring body composition and lifestyle management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stand-on, non-invasive, reusable analyzer. Utilizes bioelectrical impedance analysis (BIA) for body composition estimation. Measures body weight and impedance. Designed for home use.

Indications for Use

Indicated for healthy individuals aged 10 to 80 years for the assessment of body composition, including body fat, body water, and skeletal muscle mass, in a home environment.

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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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUN - 7 2006

Mr. Joseph Chen President Duteck Industrial Co., Ltd. 3F-2, No. 26, Lane 513 Jui-Kuang Road Taipei, Taiwan 114 R.O.C.

Re: K060642

Trade/Device Name: DUTECK (MicHealth) Body Composition Analyzer, Model BSA Series (BSA-1505, -1506, -1508, -1605, -1606, -1608, -1705, -1706, -1708) Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: February 24, 2006 Received: March 10, 2006

Dear Mr. Chen:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rottoned your Docurer of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass suned in the enactment date of the Medical Device Amendments, or to devices that provision 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 therefore, mainter and 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your Apploval), It they of be baciFederal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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.

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.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled; "Misbranding by reference to premarket notification" (21CFR Part 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Chogdon

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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Duteck Body Composition Analyzer 510(k) submission

000642 Page _ 1_of 510(k) Number: DUTECK (MicHealth) Body Composition Analyzer, Model BSA series Device Name: ( BSA-1505, BSA-1506, BSA-1508, BSA-1605, BSA-1606, BSA-1608, BSA-1705, BSA-1706, BSA-1708. )

Indications For Use:

DUTECK (MicHealth) Body Composition Analyzer, BSA series are stand-on, non-invasive, reusable analyzer, measure body weight and impedance and estimates body non-invasive, of body fat, body water and skeletal muscle mass by using BIA method (bioelectrical impedance analysis). They are intended to use by healthy people age 10 to 80, (offective lifestyles for body composition assessment in the home environment.

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use_X (Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Nancy C. Brogdon

Renroductive. Abdomi and Radiological 510(k) Number