(122 days)
Not Found
No
The description details a calculation based on a standard bioelectrical impedance method using programmed variables, with no mention of AI or ML algorithms.
No
The device measures body composition metrics but does not claim to treat, diagnose, cure, or prevent any disease or condition. It is for generally healthy adults to monitor their body metrics.
No
Explanation: The device measures body composition metrics using bioelectrical impedance analysis. While these measurements provide information about the body, they are not intended for diagnosing diseases or medical conditions. The stated "Intended Use" focuses on measuring body characteristics for generally healthy adults, not for disease detection or diagnosis.
No
The device description explicitly states it is a "Wi-Fi body scale" and describes physical components like electrodes and the process of stepping on the scale, indicating it is a hardware device with embedded 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 composition (weight, fat, water, muscle, bone, visceral fat, DCI) by passing a small electrical current through the body (Bioelectrical Impedance Analysis). This is a non-invasive method performed directly on the patient's body, not on a sample taken from the body.
- Intended Use: The intended use is to measure body composition in generally healthy adults, not to diagnose a disease or condition based on analysis of a biological sample.
Therefore, the Wi-Fi body scale, model HS5, falls under the category of a medical device but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Wi-Fi body scale, model HS5 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults,,who are not ill, feverish, have a chronic or acute disease, or a condition that affect the level of hydration such as pregnancy.
Product codes (comma separated list FDA assigned to the subject device)
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 uA, at 50 kHz, the Wi-Fi body scale calculates the body fat percentage. 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. Wi-Fi body scale, model HS5 can be used with an iPod Touch, iPhone or iPad.
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
generally healthy adults
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)
Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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
510(k) Summary JUL 2 6 2012
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA and 21 CFR 807.92.
1.0 submitter's information
| Name: | Andon Health Co., Ltd. |
|---|---|
| Address: | No 3, Jinping Road, Ya'an street, Nankai District, |
| Tianjin, | |
| P.R. China | |
| Phone number: | 86-22-6052 6161 |
| Fax number: | 86-22-6052 6162 |
| Contact: | Liu Yi |
| Date of Application: | 03/21/2012 |
2.0 Device information
| Trade name: | Wi-Fi body scale, model HS5 |
|---|---|
| Common name: | Body Analysis scale/ Electronic Body Fat Scale |
| Classification name: | Impedance plethysmograph |
3.0 Classification
Production code: MNW- Body Fat Analyzer. Regulation number: 870.2770 Classification: II Panel: Cardiovascular
4.0 Predict device information
Shenzhen Healthcare Electronic Technology Co., Ltd Manufacturer: Body Analysis Scale, Model BG 17 Device: 510(k) number: K110928
5.0 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 uA, at 50 kHz, the Wi-Fi body scale calculates the body fat percentage. This calculation is done via the Bioelectrical Impedance Method. The current is passed through the body and the impedance of the body
1
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. Wi-Fi body scale, model HS5 can be used with an iPod Touch, iPhone or iPad.
KI 20896
6.0 Intended use
Wi-Fi body scale, model HS5 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults,,who are not ill, feverish, have a chronic or acute disease, or a condition that affect the level of hydration such as pregnancy.
7.0 Summary comparing technological characteristics with predicate device
| Wi-Fi body scale, model HS5 | Body Analysis Scale, Model BG 17(K110928) | Same or not? | |
|---|---|---|---|
| Intended use | Wi-Fi body scale, model HS5 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults,,who are not ill, feverish, have a chronic or acute disease, or a condition that affect the level of hydration such as pregnancy. | Body Analysis Scale, Model BG 17 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults,,who are not ill, feverish, have a chronic or acute disease, or a condition that affect the level of hydration | Same |
2
:
| Product
Description | Wi-Fi body scale, model
HS5 is indicated to
measure body weight,
estimate body fat,
body water
percentage, body
muscle mass, bones
mass, visceral fat
rating and daily calorie
intake (DCI) using BIA
(bioelectrical
impedance analysis). | Body Analysis Scale,
Model BG 17 is
indicated to measure
body weight,
estimate body fat,
body water
percentage, body
muscle mass, bones
mass, visceral fat
rating and daily
calorie intake (DCI)
using BIA
(bioelectrical
impedance analysis). | Same |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Analytical
method | BIA (bioelectrical
impedance analysis) | BIA (bioelectrical
impedance analysis) | Same |
.
. . . . .
:
:
.
:
. . . . .
:
3
Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1 and EN/IEC 60601-1-2. Clinical testing was used to validate the effectiveness and accuracy of the device. All test results were satisfactory.
9.0 Comparison to the predict device and the conclusion
Our device Wi-Fi body scale, model HS5 is substantially equivalent to the ody Analysis Scale, Model BG 17 whose 510(k) number is K110928.
The two devices are very similar in the intended use, the design principle, the material, the energy source and the applicable standards. Wi-Fi body, scale, model HS5 can be used with an iPod Touch, iPhone or iPad.
However, the test in this submission provides demonstration that these small differences do not raise any new questions of safety and effectiveness.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUL 26 2012
Mr. Liu Yi President Andon Health Co., Ltd. No. 3 Jin Ping Street, Ya' An Road, Nankai District TIANJIN 300190 CHINA
Re: K120896
Trade/Device Name: Wi-Fi body scale, model HS5 Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: July 9, 2012 Received: July 9, 2012
Dear Mr. Yi:
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 101 too manage 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. 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
5
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,
Benjamin R. Tucker
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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Statement of Indications for Use
4120896 510(k) Number :
Device name:
Wi-Fi body scale, model HS5
Indications for use:
Wi-Fi body scale, model HS5 is indicated to measure body weight, estimate body fat, body water percentage, body muscle mass, bones mass, visceral fat rating and daily calorie intake (DCI) using BIA (bioelectrical impedance analysis). This product is for use by generally healthy adults,,who are not ill, feverish, have a chronic or acute disease, or a condition that affect the level of hydration such as pregnancy.
Prescription use Part 21 CFR 801 Subpart D)
Over-The-Counter Use YES AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Halulu
(Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number: K120896
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