BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205

• K Number: K072325
• Device Name: BODY COMPOSITION ANALYZER, EASYBODY 202, 203, 205
• Manufacturer: JAWON MEDICAL CO., LTD.
• Date Cleared: 2007-11-30 ( 102 days)
• Product Code: MNW
• Regulation Number: 870.2770

Intended Use

The EasyBody 202 and EasyBody 203 are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method. The EasyBody 205 is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), Segmental LBM, recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method. The EasyBody 202, EasyBody 203 and EasyBody 205 measure the impedance and weight of the user, and are intended for use only in healthy subjects between the age of 5-89.

Device Description

The EasyBody 202, EasyBody 203 and EasyBody 205 are non-invasive body composition analyzers intended for use only in healthy subjects between the age of 5-89. The devices employ BIA(Bio-electrical Impedance Analysis) method, 4 electrodes for EasyBody 202 and EasyBody 203, 8 electrodes for EasyBody 205, and then measure body composition using an experimentally derived algorithm. The devices are powered by four AA batteries (DC 6V) or AC adapter.

Predicate Devices

K053556

Reference Devices

K053556

AI/ML (Artificial Intelligence / Machine Learning)

No
The description explicitly states the device uses an "experimentally derived algorithm" and makes no mention of AI or ML terms.

Therapeutic

No.
The device is intended for body composition analysis and estimation in healthy subjects, not for treating any medical condition.

Diagnostic

No.
The "Intended Use / Indications for Use" states that the device is "intended to estimate PBF... and are intended for use only in healthy subjects." It highlights the estimation of various body composition metrics but does not mention the diagnosis of diseases or medical conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the devices employ BIA using electrodes and measure impedance and weight, indicating the presence of hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

• IVDs analyze samples taken from the human body. This device measures body composition on the human body using bio-electrical impedance. It does not analyze blood, urine, tissue, or any other sample removed from the body.
• The intended use is for estimating body composition parameters in healthy subjects. IVDs are typically used for diagnosing diseases, monitoring conditions, or screening for specific analytes in biological samples.
• The device description clearly states it's a non-invasive body composition analyzer. This further reinforces that it's not analyzing samples in vitro (in glass/outside the body).

The device falls under the category of a non-invasive body composition analyzer that uses the BIA method.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The EasyBody 202 and EasyBody 203 are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.

The EasyBody 205 is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), Segmental LBM, recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.

The EasyBody 202, EasyBody 203 and EasyBody 205 measure the impedance and weight of the user, and are intended for use only in healthy subjects between the age of 5-89.

Product codes

MNW

Device Description

The EasyBody 202, EasyBody 203 and EasyBody 205 are non-invasive body composition analyzers intended for use only in healthy subjects between the age of 5-89. The devices employ BIA(Bio-electrical Impedance Analysis) method, 4 electrodes for EasyBody 202 and EasyBody 203, 8 electrodes for EasyBody 205, and then measure body composition using an experimentally derived algorithm. The devices are powered by four AA batteries (DC 6V) or AC adapter.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

healthy subjects between the age of 5-89.

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical and clinical tests: The subject devices EasyBody 203 and EasyBody 203 meet the requirements of IEC 60601-1, EN 60601-1-2 and ISO 10993 series. The results of clinical comparison tests with predicate device ZEUS 9.9 demonstrate that there is no significant difference between the subjected devises and the predicate device.
Conclusions: Based on non-clinical and clinical tests, the subject devices EasyBody 202, EasyBody 203 and EasyBody 205 are as safe, as effective, and perform as well as the predicate device ZEUS 9.9. Accordingly, the subject devices are substantially equivalent to the predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K053556

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.2770 Impedance plethysmograph.

(a)
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.(b)
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.

Summary

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K072325
Page 1 of 4

Section 5

510(k) Summary

NOV 3 0 2007

[As Required by 21 CFR 807.92]

Date Prepared:	August 03, 2007
Submitter:	Jawon Medical Co., Ltd.
	#1208-12, Sinsang-Li, Jinryang-Myun, Kyungsan-city, Kyungsang-Bukdo,
	712-830, Republic of Korea
	Tel: [phone]
	Establishment Registration Number: 9616164
Contact Person:	MI Consulting Co., Ltd. (Mr. HL Jung)
	RM 624, Life Officetel, 61-3, Yoido-dong, Youngdeungpo-gu, Seoul, 150-731,
	Republic of Korea
	Tel: [phone]
	Fax: [phone]
	Email: [e-mail]
Trade Name:	Body Composition Analyzer
	Models EasyBody 202, EasyBody 203 and EasyBody 205
Common Name:	Body Fat Analyzer / Body Fat Monitor / Body Composition Monitor
Classification Name:	Body Composition Analyzer (Impedance plethysmograph) / MNW
Predicate Device:	Body Composition Analyzer Model ZEUS 9.9 (K053556)
Device Description:	The EasyBody 202, EasyBody 203 and EasyBody 205 are non-invasive body
composition analyzers intended for use only in healthy subjects between the
age of 5-89. The devices employ BIA(Bio-electrical Impedance Analysis)
method, 4 electrodes for EasyBody 202 and EasyBody 203, 8 electrodes for
EasyBody 205, and then measure body composition using an experimentally
derived algorithm. The devices are powered by four AA batteries (DC 6V) or
AC adapter.
Intended use:	Body Composition Analyzer Models EasyBody 202 and EasyBody 203 are
intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat),
Jawon Medical	EasyBody

Section 5: Page 1 of 4

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LBM(Lean Body Mass), BMR(Basic Metabolic Rate), recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.

Body Composition Analyzer Model EasyBody 205 is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), Segmental LBM, recommended daily calorie intake. daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.

The EasyBody 202, EasyBody 203 and EasyBody 205 measure the impedance and weight of the user, and are intended for use only in healthy subjects between the age of 5-89.

• Technologic characteristics: The devices EasyBody 202, EasyBody 203 and EasyBody 205 have been compared to the predicate device ZEUS 9.9 such as a comparing table of technology characteristics. The differences in this submission don't raise new questions concerning either safety or effectiveness.
• Non-clinical and clinical tests: The subject devices EasyBody 203 and EasyBody 203 meet the requirements of IEC 60601-1, EN 60601-1-2 and ISO 10993 series. The results of clinical comparison tests with predicate device ZEUS 9.9 demonstrate that there is no significant difference between the subjected devises and the predicate device.
• Conclusions: Based on non-clinical and clinical tests, the subject devices EasyBody 202, EasyBody 203 and EasyBody 205 are as safe, as effective, and perform as well as the predicate device ZEUS 9.9. Accordingly, the subject devices are substantially equivalent to the predicate device.

2

ltems	Zeus 9.9	EasyBody 202	EasyBody 203	EasyBody 205
510(k) #	K053556	New	New	New
Intended Use	Body composition
Analyzer	Same	Same	Same
Indications
for use	Estimated of:
PBF(Percentage of
Body Fat), MBF(Mass
of Body Fat),
LBM(Lean Body
Mass), TBW(Total
Body Water,
BMI(Body Mass
Index), BMR(Basic
Metabolic Rate),
Segmental LBM,
ICW(Intra-Cellular
Water), ECW(Extra-
Cellular Water), and
Ratio of ECW/TBW
Actual :
Impedance,
BMI(Body Mass
Index), weight,
WHR(Waist to Hip
Ratio)
Healthy subjects of
the age of 7-89	Estimated of:
PBF(Percentage of
Body Fat),
MBF(Mass of Body
Fat), LBM(Lean
Body Mass),
BMR(Basic
Metabolic Rate),
recommended
daily calorie intake,
daily exercise time,
sort and term of
exercise
Actual:
Impedance, weight
Healthy subjects of
the age of 5-89	Estimated of:
PBF(Percentage of
Body Fat),
MBF(Mass of Body
Fat), LBM(Lean
Body Mass),
BMR(Basic
Metabolic Rate),
recommended
daily calorie intake,
daily exercise time,
sort and term of
exercise
Actual:
Impedance, weight
Healthy subjects of
the age of 5-89	Estimated of:
PBF(Percentage of
Body Fat),
MBF(Mass of Body
Fat), LBM(Lean Body
Mass), BMR(Basic
Metabolic Rate),
Segmental LBM,
recommended
daily calorie intake,
daily exercise time,
sort and term of
exercise
Actual:
Impedance, weight
Healthy subjects of
the age of 5-89
Analysis
Method	Bio-electrical
Impedance
Analysis (BIA)	Same	Same	Same
Operating
parameters	Frequency:
1,5,50,
250,550,1000kHz	Frequency:
50kHz	Frequency:
50kHz	Frequency:
50kHz
Electrode
type	Tactile	Same	Same	Same
Number/
Placement of
Electrodes	8 electrodes
Placed on Hands and
feet(or ankle)
(Tetra-polar Electrode
method)	4 electrodes
Placed on feet
(Tetra-polar
Electrode method)	4 electrodes
Placed on feet
(Tetra-polar
Electrode method)	8 electrodes
Placed on Hands
and feet
(Tetra-polar
Electrode method)
Items	Zeus 9.9	EasyBody 202	EasyBody 203	EasyBody 205
Patient
Position	Upright	Same	Same	Same
Impedance
Measuring
Site	Whole body,
Right Arm, Right Leg,
Left Arm, Left Leg
Trunk	Foot to Foot	Foot to Foot	Whole body,
Right Arm, Right Leg,
Left Arm, Left Leg,
Trunk
Impedance
Measurement
Range	100 ~ 950 ohms	Same	Same	Same
Measuring
height	110 ~ 200 cm	100 ~ 200 cm	100 ~ 200 cm	100 ~ 200 cm
Measuring
weight	10 ~ 250 kg	1~150 kg	1~150 kg	1~150 kg
Measuring
PBF	3 ~ 50%	Same	Same	Same
Measuring
Time	Within 1 minute	About 15sec	About 15sec	About 15sec
Electrical
current
applied
during
measurement	Maximum current
360uA	Maximum current
180uA	Maximum current
180uA	Maximum current
180uA
Power
consumption	50VA	0.36VA	0.36VA	0.36VA
Power
Supply	AC120V 50/60Hz	AA Battery DC6V
or AC Adapter	AA Battery DC6V
or AC Adapter	AA Battery DC6V
or AC Adapter
Operating
ambient	Temp: 10 ~ 40 ℃
RH: 30 ~ 75%	Same	Same	Same
Storage
ambient	Temp: -20 ~ 60 ℃
RH: lower than 95%	Same	Same	Same
Dimensions
(W x L x H)	470 x 655 x 1220mm	310 x 311 x 38.5mm	300 x 356 x 79mm	300 x 300 x 369mm
Weight	45Kg	1.7kg	2.2kg	2.7kg

Jawon Medical

EasyBody

Section 5: Page 3 of 4

ે છે. રે

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4

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing its wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 3 0 2007

Jawon Medical Co., Ltd. c/o H. L. Jung MI Consulting Co., Ltd. Room 624, Life Officetel, 61-3 Yoido-dong, Youngdeungpo-gu Seoul. 150-731 REPUBLIC OF KOREA

K072325 Re:

Trade/Device Name: JAWON MEDICAL BODY COMPOSITION ANALYZER MODELS EasyBody 202, EasyBody 203, and EasyBody 205 Regulation Number: 21 CFR §870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: November 19, 2007 Received: November 21, 2007

Dear Mr. Jung:

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 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.

5

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 Center for Devices and Radiological Health's (CDRH's) 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 premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours,

Nancy Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

Section 4

Indications for Use

510(k) Number (if known): _ KO72325

Device Name: JAWON MEDICAL BODY COMPOSITION ANALYZER MODELS EasyBody 202, EasyBody 203 and EasyBody 205

Indications For Use:

The EasyBody 202 and EasyBody 203 are intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.

The EasyBody 205 is intended to estimate PBF(Percentage of Body Fat), MBF(Mass of Body Fat), LBM(Lean Body Mass), BMR(Basic Metabolic Rate), Segmental LBM, recommended daily calorie intake, daily exercise time, and sort and term of exercise using the BIA(Bio-electrical Impedance Analysis) method.

The EasyBody 202, EasyBody 203 and EasyBody 205 measure the impedance and weight of the user, and are intended for use only in healthy subjects between the age of 5-89.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Per 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Herbert Lewin

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

EasyBody 202/203/205

Section 4: Page 1 of 1