(84 days)
No
The description explicitly states the calculation is based on a fixed formula using electrical impedance, height, weight, age, and gender, and is performed via internal software with programmed variables, not through learning or adaptive algorithms.
No.
The device is used for body composition assessment (body fat, body water, body muscle mass) in healthy adults, which is a measurement function, not a therapeutic one.
No
The device is described as a "Body Fat Analyzer and Scale" that measures weight and estimates body composition (fat, water, muscle mass). Its intended use is for "body composition assessment" in healthy adults, not for diagnosing diseases or medical conditions.
No
The device description explicitly states it is a "scale device" with "four electrodes" that the patient steps on, indicating it includes physical hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device measures body weight and uses bioelectrical impedance analysis (BIA) to estimate body composition (fat, water, muscle mass). It does this by passing a small electrical current through the body.
- No Sample Analysis: The device does not analyze any samples taken from the body. It interacts directly with the body itself.
Therefore, while it provides health-related information, it does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Body Fat Analyzer and Scale measures body weight and impedance and estimates percentage of body fat, body water and body muscle mass using BIA (bioelectrical impedance analysis). It is intended for use by healthy adults 18 years of age or older who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy for body composition assessment in the home environment.
Product codes
MNW
Device Description
The patient steps on the scale device, where four electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Conmo Electronic Company Limited Body Fat Analyzer and Scale provides weight, calculates the body fat, body water and body muscle mass. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance, height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.
As discussed in the General description, the Conmo Electronic Company Limited Body Fat Analyzer and Scale is relatively simple to use. The user inputs the variable data of age, height, and gender. The user steps onto the scale and the devices measures the user weight and body impedance (via the Bioelectric Impedance through the four electrodes on the scale). The scale displays the user's weight, body fat composition, body water and body muscle mass.
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
18 years of age or older
Intended User / Care Setting
home environment.
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
Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
MAY 3 0 2014
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: March 21, 2014
- Company and Correspondent making the submission:
Name - Conmo Electronic Company Limited
Address - 3/F, Building 3, 1-5, Fusen Industrial Zone, Hangcheng Road, Xixiang
Town, Baoan, Shenzhen City, Guangdong Province, China
Telephone - +86-755-61526855
Fax - +86-755-61526855
Contact - Wei Qi
Email - charliemack@irc-us.com
- Device :
Trade/proprietary name: Body Fat Analyzer and Scale, Model 5786
Common Name : Analyzer, Body Fat
Classification Name : Impedance plethysmograph
3. Predicate Devices :
Tanita BC-533, (K040778)
-
- Classifications Names & Citations :
21CFR 870.2770, MNW, Body Fat Analyzer, Class 2
- Classifications Names & Citations :
1
5. Description :
5.1 General
The patient steps on the scale device, where four electrodes are located. The patient must step on the electrodes with bare feet, with normal moisture. Through harmless current stimulation of 500 µA, at 50 kHz, the Conmo Electronic Company Limited Body Fat Analyzer and Scale provides weight, calculates the body fat, body water and body muscle mass. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body determines the body fat. The calculation is based upon electrical impedance, height, weight, age, and gender. The calculation is performed via internal software, which uses the variables programmed in by the user. There are elements of this process that can produce erroneous readings, such as dry feet or improper-programmed data. The User's Manual defines items which could cause erroneous readings.
5.2 Directions:
As discussed in the General description, the Conmo Electronic Company Limited Body Fat Analyzer and Scale is relatively simple to use. The user inputs the variable data of age, height, and gender. The user steps onto the scale and the devices measures the user weight and body impedance (via the Bioelectric Impedance through the four electrodes on the scale). The scale displays the user's weight, body fat composition, body water and body muscle mass.
6. Indication for use :
Body Fat Analyzer and Scale measures body weight and impedance and estimates percentage of body fat, body water and body muscle mass using BIA (bioelectrical impedance analysis). It is intended for use by healthy adults 18 years of age or older who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy for body composition assessment in the home environment.
2
-
- Comparison with predicate device :
Conmo Electronic Company Limited believes that the Body Fat Analyzer and Scale, Model 5786 is substantially equivalent to the Tanita BC-533 (K040778).
- Comparison with predicate device :
-
- Safety and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1. Electromagnetic compatibility was verified with testing to IEC 60601-1-2. In Vitro cytotoxicity was verified with testing to ISO 10993-5 and skin irritation and sensitization was verified with testing to ISO 10993-10. Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory.
- Safety and Performance Data :
-
- Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Conmo Electronic Company Limited concludes that the Body Fat Analyzer and Scale, Model 5786 is safe and effective and substantially equivalent to predicate devices as described herein.
- Conclusions:
END
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 30, 2014
Conmo Electronic Company Limited % Charles Mack Principal Engineer IRC 12226 Washington Lane Parker. AZ 85344
K140594 Re:
Trade/Device Name: Body Fat Analyzer and Scale, Model 5786 Regulation Number: 21 CFR8 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: March 22, 2014 Received: April 1, 2014
Dear Charles Mack,
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,
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.
4
Page 2 - Charles Mack
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/ReportalProblem/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,
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for Beniamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Body Fat Analyzer and Scale, Model 5786
Indications for Use (Describe)
Body Fat Analyzer and Scale measures body weight and impedance and estimates percentage of body fat, body water and body muscle mass using BIA (bioelectrical impedance analysis). It is intended for use by healthy adults 18 years of age or older who are not ill, feverish, have a chronic or acute disease, or a condition that affects the level of hydration such as pregnancy for body composition assessment in the home environment.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
2 Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
2014.05.30
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