(84 days)
Not Found
No
The description focuses on standard bioelectrical impedance analysis (BIA) technology and Wi-Fi connectivity for data transfer, with no mention of AI or ML algorithms for data processing or interpretation.
No.
The device is a body analyzer measuring weight and estimating body fat mass. It does not provide any treatment or therapeutic function.
No
The device measures weight and estimates body fat mass using bioelectrical impedance analysis (BIA), which are measurements of body composition for general health purposes, not for diagnosing a specific disease or condition.
No
The device is a physical scale that uses bioelectrical impedance analysis (BIA) technology to measure body composition. While it has a Wi-Fi module for data transfer, the core medical device function is performed by the hardware components of the scale.
Based on the provided information, the Withings WBS01 Smart Body Scale is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Withings WBS01 Smart Body Scale measures weight and estimates body fat mass using bioelectrical impedance analysis, which is applied directly to the body, not to a specimen taken from the body.
- The intended use is for estimating body fat mass in generally healthy adults for home use. This is a general wellness or fitness application, not a diagnostic test for a specific disease or condition.
- The device description focuses on the physical measurement of body composition. It does not involve the analysis of biological samples.
Therefore, the Withings WBS01 Smart Body Scale falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Withings WBS01 Smart Body Scale is a body analyzer that measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only. It is not intended for being used by pregnant women or children under the age of 18.
Product codes
MNW
Device Description
WBS01 Smart Body Scale uses the BIA (Bioelectrical Impedance Analysis) technique. This method measures body composition by sending a low, safe electrical current through the body. The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'bioelectrical impedance', and is accurately measured by WBS01 Smart Body Scale.
WBS01 Smart Body Scale embeds a 802.11 (Wi-Fi) module that allows it to connect to the Internet. This module is a product add-on that is entirely independent from the body analyzer function, which does not rely on the wireless connection to carry out a bioelectrical impedance analysis and display its results. The scale uses this connectivity to offer users a complementary web and mobile interface to the scale's display, although users are instructed in the provided user manual that the only reference values are the measures displayed on the scale's display. By design. the body analysis and Wi-Fi functions never are enabled at the same time. The scale only connects to the Internet while no weight or bioelectrical impedance measures are being performed, and if a person steps on the scale while the Wi-Fi module is active, Wi-Fi immediately gets turned off therefore allowing the display and body analysis function to be enabled. The users profile details are stored locally in the scale so that they are immediately available when a bioelectrical impedance analysis needs to be performed. The scale without its Wi-Fi module is therefore an autonomous body fat analyzer, Wi-Fi functionality being a product add-on not being part of the body analyzer function and not affecting the safety and effectiveness of the body analyzer function in any way.
Device functions:
A, Measuring weight, BMI and body fat: Sten on the scale and the scale will display your weight, BMI and body fat. Unit Switch function: Change the weight unit among KG/LB/ST LB
B, Automatic recognition function: The scale can automatically recognize you based on your weight reading. Later on, the scale keeps in memory your last weight reading to recognize you. The scale can however only determine your correct identity if no other user weighs within 6.6 pound range, otherwise the scale can only narrow down the choices and displays the various identity options on screen. The appropriate identity is selected by bending left or right.
C. Warning messages Function: Lo == Low battery warning: Replace the batteries, always replace all batteries at the same time.
D. Wi-Fi Connectivity: Easily create your profile in Withings' web application and the scale will automatically retrieve it thanks to its Wi-Fi connectivity. You must enter your height, date of birth, gender and activity level (athlete/ non-athlete) while creating your profile. Benefit from a complementary interfact to view the history of your weight and body fat readings.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body
Indicated Patient Age Range
18 years of age or older. It is not intended for being used by pregnant women or children under the age of 18.
Intended User / Care Setting
home/domestic setting only
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)
Design control activities for the modification were performed and bench tests have been done to ensure that user electrical safety and wireless radiation emission is acceptable in use environment. Particular attention has been paid to those concerns and issues highlighted in the " Radio-Frequency Wireless Technology in Medical Devices Draft Guidance" FDA January 3, 2007.
Wi-Fi technology is widely used and proved to be safe and reliable. The use of the industry standard IEEE 802.11 b/g provides a high degree of confidence to the users that the coexistence of Withings WBS01 Smart Body Scale within a domestic/home environment is predictable, easily operation, and provides a high degree of assurance that there is a low risk that intentional electromagnetic radiation from the device will result in unacceptable interference with other electrical equipment in the immediate vicinity.
There is an acceptable, low risk that the radio frequency emissions will result in thermal injury to a patient or user. This is based on our FCC ID certification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Section 5 - 510(k) Summary
SEP 27 2012
Date of Summary Preparation: 06/28/2012
1. Submitter's Identifications
Submitter's Name: ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. Address: Jin'an Road, Minzhong, Zhongshan City, Guangdong, China Contact Person: Lisa Li Contact Email Address: lisha1@transtek.cn_ Tclephone: +86(760)88282982 ext. 876 Fax: +86(760)85339231
2. Correspondent's Identifications
Correspondent's Name: A03 Lab of BTS Address: No. I Fanghua Street, Hi-tech Zone, Chengdu 610041, Sichuan, China Contact Person: Leo Wang Contact Email Address: leo.w@hibts.com Telephone: 086-28-86083300 Fax: 086-20-80727399
3. Name of the Device
Device Classification Name: Analyzer, Body Composition (Impedance Plethysmograph)
Product Name: Smart Body Scale
Trade Name: Withings
Model: WBS01
Classification Panel: Cardiovascular
Common/Usual Name: Body Composition Analyzer/Scales
Product Code: MNW
Device Classification: Class II
Contraindications: Do not use the Body Scale if you have a pacemaker or other internal medical device.
4. The Predicate Devices
TRANSTEK, Glass Body Analyzer, Model GBF-830, K102191
- Device Description
5.1 Technology of the device:
Bioclectrical Impedance:
WBS01 Smart Body Scale uses the BIA (Bioelectrical Impedance Analysis) technique. This method measures body composition by sending a low, safe electrical current through the body.
1
The current passes freely through the fluids contained in muscle tissue, but encounters difficulty/resistance when it passes through fat tissue. This resistance of the fat tissue to the current is termed 'bioelectrical impedance', and is accurately measured by WBS01 Smart Body Scale.
Wireless Connectivity:
WBS01 Smart Body Scale embeds a 802.11 (Wi-Fi) module that allows it to connect to the Internet. This module is a product add-on that is entirely independent from the body analyzer function, which does not rely on the wireless connection to carry out a bioelectrical impedance analysis and display its results. The scale uses this connectivity to offer users a complementary web and mobile interface to the scale's display, although users are instructed in the provided user manual that the only reference values are the measures displayed on the scale's display. By design. the body analysis and Wi-Fi functions never are enabled at the same time. The scale only connects to the Internet while no weight or bioelectrical impedance measures are being performed, and if a person steps on the scale while the Wi-Fi module is active, Wi-Fi immediately gets turned off therefore allowing the display and body analysis function to be enabled. The users profile details are stored locally in the scale so that they are immediately available when a bioelectrical impedance analysis needs to be performed. The scale without its Wi-Fi module is therefore an autonomous body fat analyzer, Wi-Fi functionality being a product add-on not being part of the body analyzer function and not affecting the safety and effectiveness of the body analyzer function in any way.
5.2 Device functions-
A, Measuring weight, BMI and body fat:
Sten on the scale and the scale will display your weight, BMI and body fat. Unit Switch function: Change the weight unit among KG/LB/ST LB
B, Automatic recognition function:
The scale can automatically recognize you based on your weight reading. Later on, the scale keeps in memory your last weight reading to recognize you. The scale can however only determine your correct identity if no other user weighs within 6.6 pound range, otherwise the scale can only narrow down the choices and displays the various identity options on screen. The appropriate identity is selected by bending left or right.
C. Warning messages Function:
Lo == Low battery warning: Replace the batteries, always replace all batteries at the same time.
D. Wi-Fi Connectivity:
Easily create your profile in Withings' web application and the scale will automatically retrieve it thanks to its Wi-Fi connectivity. You must enter your height, date of birth, gender and activity level (athlete/ non-athlete) while creating your profile. Benefit from a complementary interfact to view the history of your weight and body fat readings.
Key function: profile definition, complementary interface.
2
6. Intended Use of Device
The Withings WBS01 Smart Body Scale is a body analyzer that measures weight and uses bioclectrical impedance analysis (BIA) technology to estimate body fat mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.
It is not intended for being used by pregnant women or children under the age of 18.
7. Summary of Substantial Equivalence
- 7.1 Difference between proposed device and the predicate device
Table: The comparison of Withings WBS01 Smart Body Scale and the predicate device, TRANSTEK Glass Body Analyzer (Model: GBF-830)
| Feature | Proposed Device:
Withings WBS01 Smart Body
Scale | Predicate Device:
TRANSTEK Glass Body Analyzer
Model: GBF-830 |
|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | ZHONGSHAN TRANSTEK
ELECTRONICS CO., LTD | ZHONGSHAN TRANSTEK
ELECTRONICS CO., LTD |
| Classification | 21 CFR 870.2770 | 21 CFR 870.2770 |
| Product Code | MNW | MNW |
| Indication for use | The Withings WBS01 Smart Body Scale measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only. | The Transtek Glass Body Analyzer measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, bone mass, and muscle mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only. |
| Device description | Withings WBS01 Smart Body Scale utilizes a “foot-to-foot” bioelectrical impedance analysis (BIA) technology to determine internal body composition. | TRANSTEK Glass Body Analyzer utilizes a “foot-to-foot” bioelectrical impedance analysis (BIA) technology to determine internal body composition. |
| Analysis method | BIA
(Bioelectrical Impedance Analysis) | BIA
(Bioelectrical Impedance Analysis) |
| Operating parameters | 50 KHz | 50 KHz |
| Number of electrodes | 4 | 4 |
| Power source | 4AAA | 4AAA |
| Operating keys | No operating key, 1 unit switch, 1 pairing button | 4 |
| IP Connectivity | 802.11b/g (Wi-Fi) | No IP connectivity |
The differences between the two devices are WBS01, I) disable these measure functions, total, body water percentage, bone mass, and muscle mass; 2) add-on a Wi-Fi (IEEE 802.11 b/g) data communication, what user option, which can transmit measurement results to PC or cellular.
| Section 5 - 510(k) Summary | ||
|---|---|---|
3
7.2 Discussion
The Withings WBS01 Smart Body Scale has an indication for use and BIA technology similar to the predicate device. The only technological difference between Withings WBS01 Smart body Scale and the predicate device is that the WBS01 embeds a 802.11 b/g (Wi-Fi) module. It is an add-on function that is entirely independent from the body analyzer function, which does not rely on the wireless connection to carry out a bioelectrical impedance analysis and display its results.
The scale uses this connectivity to offer users a complementary web and mobile interface to the scale's display, although users are instructed in the provided user manual that the only reference values are the measures displayed on the scale's display.
By design, the body analysis and Wi-Fi functions never are enabled at the same time. The scale only connects to the Internet while no weight or bioelectrical impedance measures are being performed, and if a person steps on the scale while the Wi-Fi module is active, Wi-Fi inmediately gets turned off therefore allowing the display and body analysis function to be enabled.
The users profile details are stored.locally in the scale so that they are immediately available when a bioelectrical impedance analysis needs to be performed. The scale without its Wi-Fi module is therefore an autonomous body fat analyzer, Wi-Fi functionality being a product add-on not being part of the body analyzer function and therefore not impacting the safety and effectiveness of the body analyzer function.
Design control activities for the modification were performed and bench tests have been done to ensure that user electrical safety and wireless radiation emission is acceptable in use environment. Particular attention has been paid to those concerns and issues highlighted in the " Radio-Frequency Wireless Technology in Medical Devices Draft Guidance" FDA January 3, 2007.
Wi-Fi technology is widely used and proved to be safe and reliable. The use of the industry standard IEEE 802.11 b/g provides a high degree of confidence to the users that the coexistence of Withings WBS01 Smart Body Scale within a domestic/home environment is predictable, easily operation, and provides a high degree of assurance that there is a low risk that intentional electromagnetic radiation from the device will result in unacceptable interference with other electrical equipment in the immediate vicinity.
There is an acceptable, low risk that the radio frequency emissions will result in thermal injury to a patient or user. This is based on our FCC ID certification.
Therefore, the device does not create new significant risk.
As a result, the technological difference of the device does not impact its safety and effectiveness vs. the predicate device.
8. Conclusions
The Withings WBS01 Smart Body Scale is substantially equivalent to the predicate device by having the similar indication for use, same BIA technologics and a technological difference that does not impact the safety or effectiveness of the device.
--- End of this section --
Section 5 - 510(k) Summary ーーーーー
Page 4 of 4
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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by three curved lines that suggest wings and a body. The overall design is simple and conveys a sense of official government branding.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
ZHONGSHAN TRANSTEK ELECTRONIC CO., LTD. % Mr. Leo Wang, Senior Consultant A03 Lab of BTS No. 1 Fanghua Street, Hi-tech Zone Chengdu Sichuan 610041 CHINA
Re: K121971
Trade/Device Name: Withings Smart Body Scale Model: WBS01 Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: August 30, 2012 Received: August 30, 2012
Dear Mr. Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interscate for use stated in the enclosure) to regarly management date of the Medical Device Amendments, or to comments that have been reclassified in accordance with the provisions of the Federal Food. Drug, devices that have been reclassified in door daily in a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, uicierore, market mo do recorporation of the montal registration, listing of general controls provisions of the tise, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract lability adulteration. Thease note. ODAL active labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (see above) in isting major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may round in the Ood of I oderal resguinening your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDPS Stissumice of a receive complies with other requirements of the Act
that FDA has made a determination that your device complies . You must that IDA has made a dolorimations administered by other Federal agencies. You must of any reachar statutes and regulations, but not limited to: registration and listing of modi comply with an the Act 3 requirements, merical device reporting (reporting of medical
SEP 27 2012
5
evice-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 11 you dosiro sportio any 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 note the rogaliations 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 Tou may obtain 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 K-tiska
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
Section 4 - Indications for Use
510(k) Number (if known):
K 12 1971
Device Name:
Withings Smart Body Scale Model: WBS01
Indications for Use:
The Withings WBS01 Smart Body Scale is a body analyzer that measures weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only. ・、
Prescription Use
AND/OR
メ Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off)
Division of Reproductive, Gastro-Renal, and
uctive. Gastro-Rena
Section 4 - Indications for Use
. .