Who is the manufacturer of INBODY?

Biospace Corporation Limited filed the 510(k) submission for INBODY (K130777).

What is the FDA product code for INBODY?

MNW. It is classified under 21 CFR 870.2770 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for INBODY?

510(k) clearance (submission type: Traditional).

What are the predicate devices for INBODY?

InBody 170 (K110689); InBody I30 (K110689); InBody S10 (K110689); InBody 770 (K123228); InBody 510 (K110689); InBody H20 (K123228).

Who can help prepare an FDA 510(k) submission like INBODY?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

INBODY

K130777 · Biospace Corporation Limited · MNW · Nov 25, 2013 · Cardiovascular

Device Facts

Record ID	K130777
Device Name	INBODY
Applicant	Biospace Corporation Limited
Product Code	MNW · Cardiovascular
Decision Date	Nov 25, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2770
Device Class	Class 2
Attributes	Pediatric

Intended Use

For use only in healthy subjects for Measurement of: Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Water, Body Shape Graph, Weight Control, Fat Control, Muscle Control Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for InBody720], Reactance Values [only for InBody720], Phase Angle [only for InBody720]

Device Story

InBody 120, 370, 720, and 520 are impedance plethysmograph body composition analyzers. Devices use 8-point tactile electrode system to apply electrical currents to body; measure bioelectrical impedance (resistance/reactance) at multiple frequencies. Lean tissue (high water/electrolyte content) conducts electricity better than fat/bone. Device processes impedance data to estimate body composition metrics (e.g., skeletal muscle mass, ECW, ICW, TBW, body fat, visceral fat). Used in clinical settings by healthcare professionals to manage fat/lean tissue balance. Output provided to clinicians to assist in patient management. Benefits include non-invasive assessment of fluid compartmentalization and body composition.

Clinical Evidence

Clinical performance verified through comparative studies against predicate InBody models. InBody120 vs InBody720 (n=39); InBody370 vs InBody720 (n=88); InBody520 vs InBody I30 (n=75); InBody720 vs InBody I30 (n=62). Studies confirmed performance comparability to predicates.

Technological Characteristics

Impedance plethysmograph; 8-point tactile electrode system. Multi-frequency bioelectrical impedance analysis (frequencies ranging 1kHz to 1000kHz depending on model). Power source: AC 100-240V, 50/60Hz. Dimensions vary by model. Software-based analysis of resistance and reactance values.

Indications for Use

Indicated for healthy subjects, ages 3-99, for the measurement of body composition parameters including body water, muscle mass, fat mass, and metabolic rates via bioelectrical impedance analysis.

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

InBody 170 (K110689)
InBody I30 (K110689)
InBody S10 (K110689)
InBody 770 (K123228)
InBody 510 (K110689)
InBody H20 (K123228)

Related Devices

K141483 — BIOSPACE BODY COMPOSITION ANALYZER · Biospace Corporation Limited · Sep 23, 2014
K123228 — INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) · Biospace Corporation Limited · Mar 8, 2013
K052646 — BIOSPACE BODY COMPOSITION ANALYZERS, MODELS INBODY 520, 720 AND S20 · Biospace Corporation Limited · Dec 16, 2005
K110689 — INBODY · Biospace Corporation Limited · Aug 19, 2011
K062603 — BIOSPACE BODY COMPOSITION ANALYZERS, MODEL INBODY 230 · Biospace Corporation Limited · Feb 15, 2007

Submission Summary (Full Text)

{0}------------------------------------------------ ## NOV 2 5 2013 K130777 Page 1 of 4 510(k) Summary K130777 Biospace Corporation Limited Donghyun Building, 518-10 Dogok 2 - Dong Gangnam-Gu. Seoul. KOREA 135-854 Tel : +82-2-501-3939, Fax : +82-2-501-3978 Homepage : http://www.inbody.com DATE PREPARED: February 15, 2013 Contact: Kichul Cha, CEO 1. Identification of the Devices: Proprietary-Trade Names: - Biospace Body Composition Analyzer, Model InBody 120 . - . Biospace Body Composition Analyzer, Model InBody 370 - � Biospace Body Composition Analyzer, Model InBody 720 - . Biospace Body Composition Analyzer, Model InBody 520 Classification Names: ANALYZER, BODY COMPO5ITION Common/Usual Name: Body fat meter Regulation Description: Impedance plethysmograph. Classification Panel: Cardiovascular Product Code: MNW Regulation Number: 870. 2770 Classification: = - Equivalent legally marketed devices: (Predicate device Information) 2. Biospace Body Composition Analyzer Model InBody 170, InBody J30 InBody S10, K110689 The Segmental Body Water indication was cleared in K123228, InBody 770, InBody510, InBody\$10, InBody H20. - 3. Indications for Use: For use only in healthy subjects for Measurement of: Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Water, Body Shape Graph, Weight Control, Fat Control, Muscle Control Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for In8ody720], Reactance Values [only for InBody720], Phase Angle [only for InBody720] Page 20 of 2539 {1}------------------------------------------------ Description: These devices are impedance plethysmograph body composition analyzers. These 4. devices determine body composition parameters based on bioelectrical impedance analysis (BIA). BIA relies on the differing behavior of biological tissues in response to an applied electrical current. Lean tissue is generally highly conductive because it contains large amounts of bound water and electrolytes, while fat tissue and bone are relatively poor conductors. By analyzing the response to electrical signals, BIA thereby permits differentiation of lean tissue, fat, and water and, in some instances, derivation of related body composition parameters. The total impedance resulting from BIA incorporates both resistance and capacitance components. I Impedance plethysmographic devices are used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs. Multi-frequency and segmental bioelectrical impedance analysis can estimate the distribution of body water (total body water; intra-cellular water), and can correlate with fluid compartmentalization. Assuming that body lean mass is hydrated in a constant and uniform manner; bioelectrical impedance analysis can be used to estimate body lean mass and fat mass. Body composition analysis results may be of value to health care professionals in their management of the relative balance and levels of fat and lean tissue ഗ് Safety and Effectiveness, comparison to predicate device. The results of bench, safety, and software testing indicates that the new devices are as safe and effective as the predicate device. | Devices | | InBody 170 | InBody I30 | InBody 510 | InBody 120 | InBody 370 | InBody 720 | InBody 520 | |---------------------------------|-------------------------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------| | 510(k) number | | K110689 | K110689 | K110689 | New | New | New | New | | Manufacturer | | Biospace | Biospace | Biospace | Biospace | Biospace | Biospace | Biospace | | Measurement of Estimated : | Extra- Cellular Water (ECW) | V | V | V | V | V | V | V | | | Intra- Cellular Water (ICW) | V | V | V | V | V | V | V | | | Total Body Water (TBW) | V | V | V | V | V | V | V | | | Skeletal Muscle Mass | V | V | V | V | V | V | V | | | Body Fat Mass | V | V | V | V | V | V | V | | | Lean Body Mass | V | V | V | V | V | V | V | | | Dry Lean Mass | V | V | V | V | V | V | V | | | Basal Metabolic Rates | V | V | V | V | V | V | V | | | Segmental Lean Mass | V | V | V | V | V | V | V | | | ECW/TBW | V | V | V | V | V | V | V | | | Segmental Body Fat | V | V | V | V | V | V | V | | Devices | | InBody 170 | InBody 130 | InBody 510 | InBody 120 | InBody 370 | InBody 720 | InBody 520 | | | mass | | | | | | | | | | % Segmental Body Fat | V | V | V | | | | | | | Energy expend- iture of activity | V | V | V | | | | | | | Visceral Fat Area | V | V | V | | | | | | | Segmental Body Water | (Cleared in K123228) | (Cleared in K123228) | (Cleared in K123228) | V | V | V | V | | Measure- ment of Actual : | Weight | V | V | | V | V | V | V | | | Height | | V | | V | V | V | V | | | Body Mass Index (BMI) | V | V | V | V | V | V | V | | | Impedance Values | 20, 100kHz | 5, 50, 250kHz | 1, 5, 50, 250, 500, 1,000kHz | 20, 100kHz | 5, 50, 250kHz | 1, 5, 50, 250, 500, 1,000kHz | 5, 50, 500 kHz | | | Reactance Values | | | 5, 50, 250kHz | | | 5, 50, 250kHz | | | | Phase Angle | | | 5, 50, 250kHz | | | 5,50,250k Hz | | | Measurement method | | Bioelectrical Impedance | Bioelectrical Impedance | Bioelectrical Impedance | Bioelectrical Impedance | Bioelectrical Impedance | Bioelectrical Impedance | Bioelectrical Impedance | | Electrode type | | 4 electric poles 8 points Touch type electrode measure- ment | 4 electric poles 8 points Touch type electrode measure- ment | 4 electric poles 8 points Touch type electrode measure- ment | 4 electric poles 8 points Touch type electrode measurement | 4 electric poles 8 points Touch type electrode measure- ment | 4 electric poles 8 points Touch type electrode measure- ment | 4 electric poles 8 points Touch type electrode measure- ment | | Power Source | | Input power: AC 100- 120/200- 240V, 50/60 Hz, 1.2A Output power: DC12V, 3.4A | Input power: AC 100- 120/200- 240V, 50/60Hz, 1.2A Output power: DC12V, 3.4A | Input power: AC 100- 120/200- 240V, 50/60Hz, 1.2A Output power: DC12V, 3.4A | Input power: AC 100- 120/200- 240V, 50/60 Hz, 1.2A Output power: DC12V, 3.4A | Input power: AC 100- 120/200- 240V, 50/60Hz, 1.2A Output power: DC12V, 3.4A | 100- 240V~, 50/60Hz No adapter | Input power: AC 100- 120/200- 240V, 50/60Hz, 1.2A Output power: DC12V, 3.5A | | Equipment weight | | 14.3kg | 29kg | 2kg | 5.7kg | 20 kg | 45kg | 26kg | | Equipment size | | 396(W) x 608(L) x | 360(W) x 640(L) x | 202(W) x 322(L) x | 393(W) x 516(L) x | 460(W) x 677(L) x | 520(W) x 870(L) x | 522 (W) x 843(L) x | | Devices | InBody 170 | InBody J30 | InBody S10 | InBody 120 | InBody 370 | InBody 720 | InBody 520 | | | | mm | mm | | | mm | mm | mm | | | Measurement time | 30 seconds | 30 seconds | 110 seconds | Weight measure- ment 3~5 seconds, Impedance measure- ment 5~7 seconds. | 45 seconds | Less than 1 minute for medical mode(Less than 2 minutes for research purpose mode) | 50 seconds | | | Measurement age | From age 3 ~ age 99 | From age 3 ~ age 99 | From age 3 ~ age 99 | From age 3 ~ age 99 | From age 3 ~ age 99 | From age 3 ~ age 99 | From age 3 ~ age 99 | | | Measurement weight | 10 ~ 250kg | 10 ~ 250kg | 10 ~ 250kg | 5 ~ 250kg | 10 ~ 250kg | 10 ~ 250kg | 10 ~ 250kg | | ## ર. Comparison table Page 21 of 2539 {2}------------------------------------------------ Page 22 of 2539 {3}------------------------------------------------ Discussion of Non-Clinical Testing; Electromagnetic and Safety Testing was conducted to IEC 7. Software validation was conducted. Literature was compiled and 60601-1 and IEC 60601-1-2. reviewed. ## 8. Discussion of Clinical Testing: In order to verify InBody120's clinical performance, we conducted comparison performance test between InBody120 and InBody720 that obtained FDA premarket notification under FDA law. The test was conducted from August 19rd, 2012 to August 23th, 2012 with a group of 39 examinees. In order to verify InBody370's clinical performance, we conducted comparison performance test between InBody370 and InBody720 that obtained FDA premarket notification under FDA law. The test was conducted from September 3rd, 2012 to September 5th, 2012 with a group of 88 examinees. In order to verify InBody520's clinical performance, we conducted comparison performance test between InBody520 and InBody J30 that obtained FDA premarket notification under FDA law. The test was conducted from July 2nd, 2010 to July 4th, 2010 with a group of 75 examinees. In order to verify InBody 720's clinical performance, we conducted comparison performance test between InBody J30 and InBody720 that obtained FDA premarket notification under FDA law. The test was conducted from July 2nd, 2010 to July 4th, 2010 with a group of 62 examinees As compared to our predicate devices (our own brand) these new models have 9. Conclusion: very similar technological characteristics and performed comparably to our predicates. The same scientific principles are used to produce the measurements. We therefore conclude that our new models are substantially equivalent to our predicates cleared in 2011. {4}------------------------------------------------ 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 stylized human figure with three arms or extensions reaching upwards. The figure is positioned to the right of a circular emblem that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 November 25, 2013 Biospace Corporation Limited % Daniel Kamm, P.E. Principal Consultant Kamm & Associates 8870 Ravello Ct Naples, FL 34114 K130777 Re: > Trade/Device Name: Biospace Body Composition Analyzer, Model InBody120 Biospace Body Composition Analyzer, Model InBody 370 Biospace Body Composition Analyzer, Model InBody 720 Biospace Body Composition Analyzer, Model InBody 520 Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: October 28, 2013 Received: October 30, 2013 Dear Daniel Kamm, 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. Ilisting 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. {5}------------------------------------------------ Page 2 - Daniel Kamm, P.E. 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm1115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, 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 {6}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K130777 Device Names: - 1) Biospace Body Composition Analyzer, Model InBody120 2) Biospace Body Composition Analyzer, Model InBody370 3) Biospace Body Composition Analyzer, Model InBody720 4) Biospace Body Composition Analyzer, Model InBody520 Indications for use: For use only in healthy subjects for Measurement of: Estimated: Skeletal Muscle Mass, Extra-Cellular Water (ECW), Intra-Cellular Water (ICW), Total Body Water (TBW), ECW/TBW, Body Fat, Percentage of Body Fat (PBF), Body Lean + Dry Lean, Metabolic Rates(Basal Metabolic Rates), Segmental Lean Mass, Segmental Fat Mass, % Segmental · Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Percent Body Water, Body Shape Graph, Weight Control, Fat Control, Muscle Control Actual: Weight, Body Mass Index (BMI) and Impedance Values, Height [which can require the entry of Height], Resistance Values [only for InBody720], Reactance Values [only for InBody720], Phase Angle fonly for InBody720] | Prescription Use | AND/OR | Over-The-Counter Use | X | |-----------------------------|--------|------------------------|---| | (Part 21 CFR 801 Subpart D) | | (21 CFR 807 Subpart C) | | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 1 Herbert P 2013.11.25 15:0

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