AQ-830 SLIM BODY, BODY FAT MONITOR

K052678 · Limax Electronics Co., Ltd. · MNW · Dec 27, 2005 · Cardiovascular

Device Facts

• Record ID: K052678
• Device Name: AQ-830 SLIM BODY, BODY FAT MONITOR
• Applicant: Limax Electronics Co., Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: Dec 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AQ-8303 Slim Body, Body Fat Monitor is intended for estimation of the body fat of percentage in the home..

Device Story

Hand-held, non-sterile, reusable bioimpedance meter; used in home setting by consumers. Device measures body fat percentage via bioimpedance technology. User inputs personal data; device processes electrical impedance signals to estimate body fat. Output displayed to user for personal health monitoring. Intended for healthy individuals to track body composition.

Clinical Evidence

Clinical comparison study performed against DEXA (Dual Energy X-ray Absorptiometry) as the reference standard. Subjects grouped by age, gender, weight, and height. Results indicate repeatability and accuracy of the device are statistically and clinically acceptable across all tested demographic groups.

Technological Characteristics

Bioimpedance meter; hand-held form factor. Conforms to IEC 60601-1 (safety) and IEC 60601-1-2 (EMC). Non-sterile, reusable. Operates via bioimpedance sensing principle.

Indications for Use

Indicated for estimation of body fat percentage in normal, healthy individuals aged 10 to 80 years 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.

Predicate Devices

• LONG WELL LW-6Dxx Body Fat Analyzer (K030203)
• Omron HBF-306 Body Fat Analyzer (K011652)

Submission Summary (Full Text)

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DEC 27 2005

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

- Submitter's Name: Limax ELECTRONICS CO., LTD. 1.0 5 F-1, No. 176, Keelung Road, Sec. 1 , 11069, Taipei , Taiwan Addross '

| Address: | ST. 1, No. 110, Hsing Lung Rd. |
|----------|--------------------------------|
| Phone: | 886-2-2769 9969 |
| Fax: | 886-2-2769 9558 |
| Contact: | Mr. William Chiu / President |

- AQ-830 Slim Body, Body Fat Monitor 2.0 Device Name:
- LONG WELL LW-6Dxx Body Fat Analyzer (K030203) marketed by 3.0 Predicate Device: LONG WELL ELECTRONICS CORP. &
- Omron HBF-306 Body Fat Analyzer ( K011652 )marketed by Omron Healthcare INC.
- 4.0 Device Description: AQ-830 Slim Body, Body Fat Monitor is a hand-held, non-sterile, reusable Body Fat Analyzer intended for estimation of the body fat of percentage in the home.

The AQ-8303 Slim Body, Body Fat Monitor is intended for estimation of 5.0 Intended Use: the body fat of percentage in the home..

In terms of operating specification, Safety & EMC requirements, the 6.0 Performance m terms of operating op-sandards included IEC 60601-1 and IEC Summary: device conforms to applicable on.
60601-1-2 requirements. Moreover, A comparison study with device that 00001-192 requiromono.net met absorptiometry) technology was performed use DEXA(Dual Shorgy A Tay STA) STAJ STAT Body, Body Fat Monitor.

> Subjects were grouped as male/ female, ages. The comparison study Subjects were grouped as a line a repeatability of AQ-830 Slim Body, Body Fat Monitor is statistically and clinically acceptable in all age/weight/height groups.

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## 7. Conclusions:

## 2 CE 4052678

/ - Sonsiablener
The AQ-830 Slim Body, Body Fat Monitor have the same intended use and similar to 1991 rhe T& 000 Onlin Dody Loady Fat Analyzer (K030203) marketed by LONG rations as 2012 - 11:15 and Omron HBF-306 Body Fat Analyzer( K011652 )marketed by , Omron Healthcare INC.. Moreover, bench testing contained in this submission and clinical testing Omroh realineare INO.. Morovo, before, between and and ender is and raise and supplied demonstrate that any american .
new questions of safety or effectiveness. Thus, the AQ-830 Slim Body, Body Fat Monitor is substantially equivalent to the predicate devices.

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Image /page/2/Picture/2 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus is depicted with a bird-like figure with three lines representing the wings and a snake-like figure at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is arranged in a circular fashion around the caduceus.

DEC 2 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

LIMAX ELECTRONICS CO., LTD. c/o Ms. Jennifer Reich Harvest Consulting Corp. 2904 N. Boldt Drive FLAGSTAFF AZ 86001

Re: K052678

Trade/Device Name: AQ-830 Slim Body, Body Fat Monitor Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: September 27, 2005 Received: September 28, 2005

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 (Premarket Approval), it may be subject to such 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 clectronic 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 Scetion 5 (t(k) This letter will allow you to begin marketing your dones of your device of your device to a legally premarket notification. The FDA midnig of stossantal common 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 laboring organise (
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 prematic notification" (21 CFR Also, please note the regulation entired, "rinsolation on your responsibilities under the Act from the 807.97). You may obtain other general monmation on Jour September Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

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):_____________________________________________________________________________________________________________________________________________________

Device Name: AQ-830 Slim Body, Body Fat Monitor Limax ELECTRONICS CO., LTD.

Indications For Use:

The device is a noninvasive bioimpedance meter used to estimate body fat
. The device is a noninvasive built peading more as a mormal, healthy people only,
percentage in the home setting. The device is for normal, healthy people only,
percentage in the rege range is 10 to 80 years old.

The device is to be used in a home environment having normal temperature and humidity conditions.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use __ (21 CFR 807 Subpart C)

V

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Cr. Leggett

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices K052678
510(k) Number

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