LONG WELL LW-6DXX SERIES BODY FAT ANALYZER

K030203 · Long Well Electronics Corp. · MNW · Apr 21, 2003 · Cardiovascular

Device Facts

• Record ID: K030203
• Device Name: LONG WELL LW-6DXX SERIES BODY FAT ANALYZER
• Applicant: Long Well Electronics Corp.
• Product Code: MNW · Cardiovascular
• Decision Date: Apr 21, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The LONG WELL Body Fat Analyzer is intended for estimation of the body fat of percentage in the home.

Device Story

Hand-held, non-sterile, reusable body fat analyzer; uses bioimpedance technology to estimate body fat percentage. Operated by user in home environment. Device measures electrical impedance; calculates body fat percentage based on input data. Output displayed to user for personal health monitoring. Benefits include non-invasive, convenient body fat estimation.

Clinical Evidence

Comparison study performed against DEXA (Dual energy X-ray absorptiometry) technology. Subjects grouped by gender, age, weight, and height. Results demonstrated that clinical repeatability is statistically and clinically acceptable across all tested groups.

Technological Characteristics

Bioimpedance analyzer; hand-held form factor. Conforms to IEC 60601-1 (safety) and IEC 60601-1-2 (EMC) standards. Non-sterile, reusable.

Indications for Use

Indicated for estimation of body fat percentage in healthy individuals aged 10 to 80 years. For home use in room temperature and normal environmental conditions.

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

• Omron HBF-306 Body Fat Analyzer (K011652)

Submission Summary (Full Text)

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## APR 2 1 2003

## 510(K) SUMMARY

Image /page/0/Picture/2 description: The image shows the text "KO30203" on the first line. The second line of the image shows the text "PAGE 1 OF 2". The text appears to be handwritten and is in black ink. The image is a close-up of the text.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92

| 1.0 | Submitter's Name: | LONG WELL ELECTRONICS CORP. |
|-----|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Address: | 4F, No. 250, Pei Shen Road Sec.3, Shen Keng Hsiang, Taipei<br>Hsien, Taiwan 222, R.O.C |
| | Phone: | 001-886-2-26625390 |
| | Fax: | 001-886-2-26623532 /26627020 |
| | Contact: | Mr. Willan Yang, Executive Vice President |
| 2.0 | Device Name: | LONG WELL LW-6Dxx Series Body Fat Analyzer |
| 3.0 | Series Models Description: | LONG WELL LW-6Dxx Series Body Fat Analyzer includes the<br>following models.where<br>LW-6Dxx<br>The first Character (1-9,0) is for the minor change revision of<br>device (The Minor change meaning device change that do not<br>affect the conformity test result of EMC & Safety.<br>The second Character (1-9,0) is for the color or Artwork of<br>Device's housing<br>(for example LW-6D11, is for the first revision of device design<br>and the present version of color & artwork) |
| 4.0 | Predicate Device: | LONG WELL LW-6Dxx Series Body Fat Analyzer has similar<br>general design with Omron HBF-306 Body Fat<br>Analyzer(K011652) marketed by<br>Omron Healthcare INC. |
| 5.0 | Device Description: | LONG WELL LW-6Dxx Series Body Fat Analyzer is a hand-held,<br>non-sterile, reusable Body Fat Analyzer intended for estimation of<br>the body fat of percentage in the home. |
| 6.0 | Intended Use: | The LONG WELL Body Fat Analyzer is intended for estimation of<br>the body fat of percentage in the home. |

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#### 8.0 Performance Summary:

2 PAGE 2 OF In terms of operating specification, Safety & EMC requirements, the device conforms to applicable standards included IEC 60601-1 and IEC 60601-1-2 requirements. Moreover, A comparison study with device that use DEXA(Dual energy X-ray absorptiometry) technology was performed to validate the performance of the LONG WELL LW-6Dxx Series Body Fat Analyzer.

K030203

Subjects were grouped as male/ female, ages. The comparison study demonstrated that the clinical repeatability of LONG WELL LW-6Dxx Series Body Fat Analyzer is statistically and clinically acceptable in all age/weight/height groups.

#### Conclusions: 8.

The LONG WELL LW-6Dxx Series Body Fat Analyzer have the same intended use and similar technological characteristics as Omron HBF-306 Body Fat Analyzer( K011652 )marketed by Omron Healthcare INC. Moreover, bench testing contained in this submission and clinical testing supplied demonstrate that any differences in their technological characteristics do not raise and new questions of safety or effectiveness. Thus, the LONG WELL LW-6Dxx Series Body Fat Analyzer is substantially equivalent to the predicate devices.

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Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized human figure with three overlapping profiles, suggesting a sense of community and support. The figure is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.

APR 2 1 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Long Well Electronics Corporation c/o Ms. Jennifer Reich Harvest Consulting Corporation 3892 South America West Trail FLAGSTAFF AZ 86001

Re: K030203

Trade/Device Name: Long Well Electronics Body Fat Analyzer (LW-6Dxx Series) Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: 74 MNW Dated: January 12, 2003 Received: January 21, 2003

Dear Ms. Reich:

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 your 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 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):

#### LONG WELL LW-6DXX Series Body Fat Analyzer DEVICE NAME: LONG WELL ELECTRONICS CORP..

### INDICATIONS FOR USE:

The device is a noninvasive bioimpeadance analyzer used to estimate body fat percentage in home use. The device is for normal, healthy person only, and the applicable age range is 10 to 80 years old.

The device is to be used in the ENVIRONMENT of room temperature & normal environment condition.

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

Concurrence of CDRH, Office of Device Evaluation

Prescription Use OR
(Per 21 CFR 801.109)

(Md. & Date Sign Off)

510(k) Number

Over-The-Counter ' (Optional Format)

V