Who is the manufacturer of INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)?

Biospace Corporation Limited filed the 510(k) submission for INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B) (K123228).

What is the FDA product code for INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)?

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 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)?

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

What are the predicate devices for INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)?

InBody170 (K110689); InBodyJ30 (K110689); InBodyS10 (K110689).

Who can help prepare an FDA 510(k) submission like INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)?

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 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)

K123228 · Biospace Corporation Limited · MNW · Mar 8, 2013 · Cardiovascular

Device Facts

Record ID	K123228
Device Name	INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)
Applicant	Biospace Corporation Limited
Product Code	MNW · Cardiovascular
Decision Date	Mar 8, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2770
Device Class	Class 2
Attributes	Pediatric

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. Body Shape Graph Actual: Weight [except for Model InBodyS10, which requires the manual entry of weight], Body Mass Index (BMI) and Impedance Values, Height [except for Model InBody S10 and InBody H20/InBody H20(B, which requires the manual entry of Height], Resistance Values [only for InBody770, InBody S10], Reactance Values [for InBody770, InBody S10], Phase Angle [for InBody770, InBody S10]. The InBody H20 and the InBody H20B) are identical except that t he (B) model has Bluetooth capability for data transfer.

Device Story

InBody series (770, 570, S10, H20) are impedance plethysmograph body composition analyzers. Devices apply electrical currents to the body via 8-point touch-type electrodes; measure resistance, reactance, and impedance across multiple frequencies. Lean tissue (high water/electrolyte content) is conductive; fat/bone are resistive. Device transforms impedance data into body composition metrics (e.g., TBW, ICW, ECW, skeletal muscle mass, body fat, visceral fat) using established bioelectrical impedance analysis (BIA) principles. Used in clinical settings by healthcare professionals to manage fat/lean tissue balance. Output provided as numerical values and graphs for clinical decision-making regarding patient body composition and fluid status. H20(B) model includes Bluetooth for data transfer.

Clinical Evidence

Clinical performance verified via comparison tests against predicate InBody J30. InBody570 tested with 68 subjects; InBody770 with 40 subjects; InBody S10 with 43 subjects; InBody H20/H20(B) with 40 subjects. Results demonstrated comparable performance to predicate devices.

Technological Characteristics

Impedance plethysmograph using multi-frequency bioelectrical impedance analysis (BIA). Employs 4-pole, 8-point touch-type electrodes. Measures resistance, reactance, and phase angle. Connectivity includes Bluetooth (H20(B) model). Power sources vary by model (AC 100-240V or DC 6V battery). Software performs segmental body water calculations based on lean mass.

Indications for Use

Indicated for healthy subjects (age 1-99, model dependent) for the measurement and estimation 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

InBody170 (K110689)
InBodyJ30 (K110689)
InBodyS10 (K110689)

Submission Summary (Full Text)

{0}------------------------------------------------ ## 510(k) Summary K123228 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: January 30, 2013 Contact: Kichul Cha, CEO - 1. Identification of the Device: Proprietary-Trade Names: InBody770, InBody570, InBody S10, InBody H20/inBody H20(B) Classification Names: ANALYZER, BODY COMPOSITION Common/Usual Name: Body fat meter Regulation Description: Impedance plethysmograph. Classification Panel: Cardiovascular Product Code: MNW Regulation Number: 870. 2770 Classification: II - Equivalent legally marketed devices: (Predicate device Information) Biospace Body Composition 2. Analyzer Model InBody170, Model InBodyJ30 InBodyS10 K110689 - Indications for Use InBody770, InBody570, InBody S10, InBody H20/InBody H20(B) 3. 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 Body Fat, Energy Expenditure of Activity, Visceral Fat Area (VFA), Visceral Fat Level, Segmental Body Water, Body Shape Graph Actual: Weight [except for Model InBodyS10, which requires the manual entry of weight], Body Mass Index (BMI) and Impedance Values, Height [except for Model InBody S10 and InBody H20/InBody H20® which requires the manual entry of Height], Resistance Values [only for InBody770, InBody S10], Reactance Values [for InBody 510], Phase Angle [for InBody770, InBody S10] The InBody H20 and the InBody H20(B) are identical except that the (B) model has Bluetooth capability for data transfer. - Description of the Device: InBody770, InBody570, InBody H20/InBody H20%are 4. impedance plethysmograph body composition analyzers. These 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 MAR 8 2013 {1}------------------------------------------------ resistance and capacitance components. 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; extra-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. The InBody H2O and the InBody H20() are identical except that the (5) model has Bluetooth capability for data transfer. - 5. Safety and Effectiveness, comparison to predicate device. The results of bench and software testing indicates that the new devices are as safe and effective as the predicate device. | Devices | InBody 170 | InBody J30 | InBody S10 | InBody 770 | InBody 570 | InBody S10 | InBody H20/ H20(B) (B) has Bluetooth data module. | | |-------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------| | 510(k) number | K110689 | K110689 | K110689 | New | New | New | New | | | Manufacturer | Biospace | Biospace | Biospace | Biospace | Biospace | Biospace | Biospace | | | Measurement of Estimated : | Extra- Cellular Water(EC W) | 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 | | Devices | | InBody 170 | InBody J30 | InBody S10 | InBody 770 | InBody 570 | InBody S10 | InBody H20/ H20Ⓑ Ⓑ has Bluetooth data module. | | | Segmenta l Lean Mass | V | V | V | V | V | V | V | | | ECW/TB W | V | V | V | V | V | V | V | | | Segmenta l Body Fat mass | V | V | V | V | V | V | V | | | % Segmenta l Body Fat | V | V | V | V | V | V | V | | | Energy expenditu re of activity | V | V | V | V | V | V | V | | | Visceral Fat Area | V | V | V | V | V | V | V | | | Segmenta l Body Water | | | | V | V | V | V | | Measurement of Actual: | Weight | V | V | | V | V | | V | | | Height | | 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 | 1, 5, 50, 250, 500, 1,000kHz | 5, 50, 500kHz | 1, 5, 50, 250, 500, 1,000kHz | 20, 100kHz | | | Reactance Values | | | 5,50,250 kHz | 5,50,250 kHz | | 5,50,250kHz | | | | Phase Angle | | | 5,50,250kHz | 5,50,250kHz | | 5,50,250kHz | | | Measurement method | | Bioelectrical Impedance | Bioelectrical Impedance | Bioelectrical Impedance | Bioelectrical Impedance | Bioelectrical Impedance | Bioelectrical Impedance | Bioelectrical Impedance | | Devices | InBody 170 | InBody J30 | InBody S10 | InBody 770 | InBody 570 | InBody S10 | InBody H20/ H20B ® has Bluetooth data module. | | | 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 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 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, 50/60 Hz, 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, 50/60 Hz, 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, 50/60 Hz, 1.2A Output power: DC12V, 3.4A | DC 6V (AA type battery, 1.5V×4EA) | | | Equipment weight | 14.3kg | 29kg | 2kg | 38kg | 24kg | 2kg | 2.7kg | | | Equipment size | 396(W) x 608(L) x 955(H) : mm | 360(W) x 640(L) x 2235(H) : mm | 202(W) x 322(L) x 53(H): mm | 526(W) x 854(L) x 1175(H): mm | 522(W) x 893(L) x 1113(H): mm | 202(W) x 322(L) x 53(H): mm | 310.3(W) x 356.4(L) x 58.3(H) :mm | | | Measurement time | 30 seconds | 30 seconds | 110 seconds | 50 seconds | 50 seconds | 110 seconds | 5 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 1 ~ age 99 | From age 3 ~ age 99 | From age 3 ~ age 99 | | | Measurement weight | 10 ~ 250kg | 10 ~ 250kg | 10 ~ 250kg | 10 ~ 270kg | 5 ~ 250kg | 10 ~ 250kg | 10 ~ 200kg | | #### Comparison Table 6. {2}------------------------------------------------ K123228 PAGE 3 OF 5 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text "K 123228" on the first line and "PAGE 4 OF 5" on the second line. The text is written in a handwritten style with a black ink. The image appears to be a page number from a document. - 7. Discussion of Non-Clinical Testing: Electromagnetic and Safety Testing was conducted to IEC 60601-1 and IEC 60601-1-2. Software validation was conducted. Literature was compiled and reviewed. - 8. Discussion of Clinical Testing: In order to verify InBody570's clinical performance, we conducted comparison performance test between InBody570 and InBody J30 that obtained FDA premarket notification under FDA law. The test was conducted with a group of 68 examinees. In order to verify InBody770's clinical performance, we conducted comparison performance test between InBody770 and InBody J30. The test was conducted with 40 examinees. In order to verify InBody S10's clinical performance, we conducted comparison performance test between InBody \$10 and InBody3.0 that obtained FDA premarket notification under FDA law. The test was conducted with a group of 43 examinees. {4}------------------------------------------------ # K123228 PAGE 5 OF 5 In order to verify InBody H20/InBody H20(B)'s clinical performance, we conducted comparison performance test between InBody H20/InBody H20() and InBody J30. The test was conducted with 40 examinees. - There is only one difference in the indications for use between our new devices and 9. Conclusion: our predicates: The addition of Segmental Body Water. This is based on a computation that is Segmental Body Water is calculated using Segmental Lean Mass supported by reference papers: that is already submitted in InBody 130 (K110689). Body Water can be calculated by Lean Body Mass (= Fat Free Mass) according to fact which is founded in the attached reference papers. As in papers they tell body water/fat free mass is 0.73. So, InBody using this fact can measure segmental body water from segmental lean mass (segmental fat free mass). As compared to our predicate devices (our own brand) these new models have 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. {5}------------------------------------------------ Image /page/5/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" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 #### March 8, 2013 Biospace Corporation Limited Kamm & Associates % Mr. Daniel Kamm Principal Engineer 8870 Ravello Ct NAPLES FL 34114 Re: K123228 Trade/Device Name: 1) Biospace Body Composition Analyzer, Model InBody770 2) Biospace Body Composition Analyzer, Model InBody570 3) Biospace Body Composition Analyzer, Model InBody S10 - 4) Biospace Body Composition Analyzer, Model InBody H20/InBody H20(B) Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: January 30, 2013 Received: February 5, 2013 Dear Mr. 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, 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. {6}------------------------------------------------ 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/ucm115809.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/Resourcesfor You/Industry/default.htm. Sincerely yours, HerbertLerner -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 {7}------------------------------------------------ ### Indications for Use ### 510(k) Number (if known): K123228 #### Device Name: - Biospace Body Composition Analyzer, Model InBody770 1) - Biospace Body Composition Analyzer, Model InBody570 2) - 3) Biospace Body Composition Analyzer, Model InBody S10 - 4) Biospace Body Composition Analyzer, Model InBody H20/InBody H20(B) #### 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. Body Shape Graph Actual: Weight [except for Model InBodyS10, which requires the manual entry of weight], Body Mass Index (BMI) and Impedance Values, Height [except for Model InBody S10 and InBody H20/InBody H20(B, which requires the manual entry of Height], Resistance Values [only for InBody770, InBody S10], Reactance Values [for InBody770, InBody S10], Phase Angle [for InBody770, InBody S10]. The InBody H20 and the InBody H20B) are identical except that t he (B) model has Bluetooth capability for data transfer. | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ Prescription . | ----------- AND/OR | The ounter VAT. | |----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--------------------------| | (Part 21 CFR 801 Subpart Acres of the confession for the contributed and the contributed to the contributed to the contributed to the contributed to the contributed to the contributed to the contribu ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | | 121 CER 807 Subpart ( 1) | (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Image /page/7/Picture/14 description: The image shows the name "Herbert P. Lerner - S" in a bold, sans-serif font. The letters "P" and "L" are stylized with concentric lines, creating a unique visual effect. The name is likely a person's name, possibly associated with a business or organization. The overall impression is professional and distinctive. Division Sign-Off) n of Reproductive. Gastro-Renal, and 100k) Number

INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)

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INBODY 770, INBODY 570, INBODY S10, INBODY H20/INBODY H20(B)

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

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Special Control Matches

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