BODY COMPOSITION ANALYZER

K140045 · Jawon Medical Co., Ltd. · MNW · Feb 18, 2015 · Cardiovascular

Device Facts

• Record ID: K140045
• Device Name: BODY COMPOSITION ANALYZER
• Applicant: Jawon Medical Co., Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: Feb 18, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

These devices calculates and estimates body composition parameters by using measured weight and impedance and entered height, age and gender. It shows body composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, Goal setter. In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk). These devices can only estimate the body composition parameters with the exception of Weight, BMI, and impedance. These devices are only for use with generally healthy individuals of a specified age range.

Device Story

Jawon Body Composition Analyzers (X-CONTACT 350, 350M, 350S) are bioelectrical impedance analysis (BIA) devices. They measure weight and electrical impedance via electrodes while users input height, age, and gender. The device processes these inputs to estimate body composition metrics, including lean body mass, total body water, intracellular/extracellular water, BMI, body fat mass/percentage, and basal metabolic rate. Whole-body models provide additional segmental analysis (arms, legs, trunk) and waist-to-hip ratios. Used in clinical or home settings by generally healthy individuals. Output is displayed to the user to assist in monitoring body composition and setting health goals. The device provides estimates only; weight, BMI, and raw impedance are direct measurements.

Clinical Evidence

Performance testing was conducted to compare the subject devices against predicate devices. Results demonstrated no significant difference in measurements. The devices meet IEC 60601-1 and IEC 60601-1-2 safety and electromagnetic compatibility standards.

Technological Characteristics

Bioelectrical impedance analysis (BIA) device. Measures weight and electrical impedance. Provides estimates for body composition parameters. Complies with IEC 60601-1 (safety) and IEC 60601-1-2 (EMC).

Indications for Use

Indicated for generally healthy individuals to estimate body composition parameters including weight, lean body mass, body water, BMI, body fat, and basal metabolic rate using impedance and weight measurements.

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

• ioi 353 (K092431)
• EasyBody 202 (K072325)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 18, 2015

Jawon Medical Co., Ltd. Won Hee Park President 1208-12, Sinsang-ri, Jinryang-eup Kyungsan-city Kyungsang-Bukdo 712-830 Republic of Korea

Re: K140045

> Trade/Device Name: Jawon Body Composition Analyzers, Model X-CONTACT 350; X-CONTACT 350M; X-CONTACT 350S Regulation Number: 21 CFR 870.2770 Regulation Name: Analyzer, body composition Regulatory Class: II Product Code: MNW Dated: November 7, 2014 Received: November 20, 2014

Dear Won Hee Park,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Herbert P. Lerner -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K140045

## Device Name: Jawon Body Composition Analyzers Model X-CONTACT 350; X-CONTACT 350M; X-CONTACT 350S

Indications For Use:

These devices calculates and estimates body composition parameters by using measured weight and impedance and entered height, age and gender. It shows body composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat, Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control, Goal setter.

In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).

These devices can only estimate the body composition parameters with the exception of Weight, BMI, and impedance. These devices are only for use with generally healthy individuals of a specified age range.

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

Over-The-Counter Use X (21 CFR 801 Subpart C)

(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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#1208-12 Sinsang-ri Jinryang-eup Kyungsan-City. Kyungsan-Bukdo712-830 Republic of Korea Tel-82-53-856—0993 Fax [phone]

Doc. No. 4 510(K) Summary [K140045]

[As required by 21 CFR 807.92]

Date Prepared: 02/18/15

| Submitter: | Jawon Medical Co. LTD.<br>#1208-12 Sinsang-ri Jinryang-eup Kyungsan-City.<br>Kyungsan-Bukdo712-830 Republic of Korea<br>Tel-82-53-856-0993 Fax [phone]<br>Establishment Registration Number 9616164 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | MEDMONTS Co. Ltd. (W.S. Park)<br>Life-officetel 320, 40 63 ro, Youngdeungpo-gu, Seoul 150-731, |
| Trade Name: | Body Composition Analyzer<br>Model X-Contact 350, X-Contact 350M, X-Contact 350S |
| Common Name: | Body Fat Analyzer/Body Fat Monitor/Body Composition Monitor |
| Classification Name: | Body Composition Analyzer (Impedance plethysmograph) /MNW |
| Predicate Device: | Body Composition Analyzer Models ioi 353{K092431) and EasyBody<br>202(K072325) |

X-Contact 350, X-Contact 350M, X-Contact 350S A list of 510(k) Devices To Be Cleared

| No. | Model Name | Indication for Use |
|-----|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | X-Contact 350 | Whole Body Composition Analyzer<br>These devices calculates and estimates body composition parameters by using<br>measured weight and impedance and entered height, age and gender. It shows body<br>composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra<br>Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat,<br>Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control,<br>Goal setter.<br><br>In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of<br>E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).<br><br>These devices can only estimate the body composition parameters with the exception<br>of Weight, BMI, and impedance. These devices are only for use with generally healthy<br>individuals of a specified age range. |
| 2 | X-Contact 350M | Upper Body Composition Analyzer<br>These devices calculates and estimates body composition parameters by using |

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| 3 | X-Contact 350S | Lower Body Composition Analyzer<br>These devices calculates and estimates body composition parameters by using<br>measured weight and impedance and entered height, age and gender. It shows body<br>composition of Weight, Standard weight, Lean Body Mass, Total Body Water, Intra<br>Cellular Water, Extra Cellular Water, B.M.I. (Body Mass Index), Mass of Body Fat,<br>Percent of Body Fat, Basal Metabolic Rate, Impedance, Body Type, Target to Control,<br>Goal setter.<br>In case of whole body, it shows more items including Waist to Hip Ratio, Ratio of<br>E.C.W. /T.B.W., Segmental analysis (lean body mass of arms, legs, and trunk).<br>These devices can only estimate the body composition parameters with the exception<br>of Weight, BMI, and impedance. These devices are only for use with generally healthy<br>individuals of a specified age range. |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technologic<br>Characteristics | These subject devices X-CONTACT 350, X-CONTACT 350M, X-CONTACT<br>350S have same intended use and technology characteristics as predicate<br>devices. See enclosed document number 9 (Substantial Equivalence<br>Discussion). The differences in this submission do not raise new questions<br>concerning either their safety or effectiveness. | |
| Non-Clinical and<br>Clinical Tests | These subject devices X-CONTACT 350, X-CONTACT 350M, and X-CONTACT<br>350S meets the requirements of IEC 60601-1, IEC 60601-1-2 and in-house test<br>criteria. The results of performance tests using X-Contact 350 demonstrated that<br>there is no significant difference in measurements. See the enclosed document<br>number 15 (Performance Test-Clinical) | |
| Conclusion: | Based on non-clinical and clinical tests, the modified devices X-CONTACT 350,<br>X-CONTACT 350M, and X-CONTACT 350S, are as safe, as effective, and<br>perform as predicate devices perform. (See document number 9-Substantial<br>Equivalents Discussion). Accordingly the subject devices X-CONTACT 350, X-<br>CONTACT 350M, and X-CONTACT 350S, are substantially equivalent to the<br>predicate devices | |