TRANSTEK GLASS BODY FAT ANALYZER

K123781 · Zhongshan Transtek Electronics Co., Ltd. · MNW · Jan 9, 2013 · Cardiovascular

Device Facts

• Record ID: K123781
• Device Name: TRANSTEK GLASS BODY FAT ANALYZER
• Applicant: Zhongshan Transtek Electronics Co., Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: Jan 9, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Intended Use

The Transtek Glass Body Fat Analyzer measure 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 Story

Device is a body composition analyzer/scale for home use. Inputs: electrical current passed through body via BIA technology; resistance (impedance) measured to estimate body fat, water, muscle, and bone mass. Device also functions as a conventional weight scale. Operation: user stands on scale; device calculates metrics and displays results on integrated LCD. Device includes wireless network module to transmit data to a bridge device, which relays data to an internet server for storage and viewing on end-user devices (PC, mobile, tablet). Wireless function is independent of BIA measurement. Benefits: provides users with health and fitness metrics for personal monitoring.

Clinical Evidence

No clinical data. Bench testing only. Performance tests, risk management, and design verification confirmed that the addition of wireless functionality does not raise new safety or effectiveness questions.

Technological Characteristics

BIA technology; electrical current measurement. Wireless network module for data transmission. Standards: ISO14971 (risk management), IEC60601-1 (electrical safety), IEC60601-1-2 (EMC), FCC Part 15 (EMI). Integrated LCD display. Home/domestic use form factor.

Indications for Use

Indicated for generally healthy adults 18 years of age or older for estimation of body fat, total body water percentage, bone mass, and muscle mass, and weight measurement. Contraindicated for individuals with pacemakers or other internal medical devices.

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

• TRANSTEK, Glass Body Fat Analyzer, Model GBF-950-D (K112932)

Submission Summary (Full Text)

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## Section 5 - 510(k) Summary

Date of Summary Preparation: 11/30/2012

### 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: [e-mail] Telephone: [phone] ext. 876 Fax: [phone]

#### 2. Correspondent's Identifications

Correspondent's Name: A03 Lab of BTS Address: No.1 Fanghua Street, Hi-tech Zone, Chengdu City, Sichuan, China Contact Person: Leo Wang Contact Email Address: [e-mail] Telephone: [phone] Fax: [phone]

#### 3. Name of the Device

Device Classification Name: Analyzer, Body Composition (Impedance Plethysmograph) Product Name: Glass Body Fat Analyzer Trade/Proprietary Name: TRANSTEK Glass Body Fat Analyzer Model: LS206-E Classification Panel: Cardiovascular Common/Usual Name: Body Composition Analyzer/Scales Product Code: MNW Device Classification: Class II Contraindications: Do not use the Analyzer if you have a pacemaker or other internal medical device.

#### '4. The Predicate Devices

TRANSTEK, Glass Body Fat Analyzer, Model GBF-950-D. K112932

#### 5. Device Description

Transtek Glass Body Fat Analyzer uses BIA (Bioelectrical Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water, muscle mass and bone mass. The electrical current is low and may not be felt. The current passes freely through the

Section 5 - 510(k) Summary

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## AN 0 9 2013

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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 Glass Body Fat Analyzer LS206-E.

This method simultaneously calculates your personal weight, body fat, total body water, muscle mass and bone mass, giving you a more accurate reading of your overall health and fitness.

This scale stores the personal data of up to 4 users. As well as being an analyzer, this device can be used as a conventional weight scale.

Transtek Glass Body Fat Analyzer LS206-E embeds a Wireless network connections module that allows it to connect to nearby receiving end (such as specific equipment that named Bridge) which is connected to the Internet. Once measurement is over, the LCD of device displays results. And the device will start to send out data. The Bridge receive / storage, and transmission data to Internet server. Thus users can receive, and display/storage, measurement results from LS206-E unit through their end devices (e.g. PC, cellular, tablet) that connected Internet.

#### 6. Intended Use of Device

The TRANSTEK Glass Body Fat Analyzer measure weight and uses bioelectrical impedance analysis (BIA) technology to estimate body fat, total body water percentage, muscle mass, and bone mass in generally healthy adults 18 years of age or older. It is intended for use in the home/domestic setting only.

#### 7. Design Control Activities and Performance Tests Summary

Design control activities for this modification were performed and bench tests have been done. Those performance tests, risk management, and design verification tests provide demonstration that the difference does not raise any new questions of safety and effectiveness.

LS206-E conforms to the following standards:

ISO14971, Risk management to medical devices

IEC60601-1, Electrical safety; IEC60601-1-2, Electromagnetic compatibility

FCC Part 15, EMI tests of FCC Radiation & RF rules and regulations

Explanation: The new wireless function does not affect body analyzer measurement function. Therefore we have not done the Clinical test.

#### 8. Summary of Substantial Equivalence

8.1 Differences between proposed device and the predicate device

The only significant function difference between the two devices is that LS206-E add-on a wireless data communication, what user option, which can transmit measurement results to those end devices which connected Internet.

More modification details are described in this submission.

Section 5 - 510(k) Summary

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#### 8.2 Discussion

The Transtek Glass Body Fat Analyzer LS206-E has identical indication for use, fundamental scientific technology, energy type, dimensional specifications, and similar performance specifications, software/firmware, functions, labeling to the predicate device.

The only function difference between LS206-E and the predicate device is that the modified device provides user an optional wireless data transmission. It is an add-on function that is entirely independent from the body analyzer function, which does not reply on the wireless connection to carry out a bioelectrical impedance analysis and display its results. Thus the wireless data transmission function does not affect the safety and effectiveness of the body analyzer function.

#### 9. Conclusions

The Transtek Glass Body Fat Analyzer LS206-E is substantially equivalent to the predicate device GBF-950-D by having the identical indication for use, identical technologies, and an add-on function which does not impact the safety and effectiveness of the device.

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Image /page/3/Picture/1 description: The image shows a circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human figures or shapes, arranged in a way that suggests movement or progress.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 9, 2013

ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. % Mr. Leo Wang Senior Consultant A03 Lab of BTS No. 1 Fanghua Street, Hi-tech District CHENGDU SICHUAN CHINA 610041

Re: K123781

Trade/Device Name: Transtek Glass Body Fat Analyzer Models: LS206-E Regulation Number: 21 CFR§ 870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: December 10, 2012 Received: December 10, 2012

Dear Mr. Wang:

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.

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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 (OS) 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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Herbert R. Lerner

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

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## Section 4 - Indications for Use

510(k) Number (if known):

KI23781/

Device Name:

Transtek Glass Body Fat Analyzer Models: LS206-E

Indications for Use:

The Transtek Glass Body Fat Analyzer measure 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.

Prescription Use

AND/OR

× Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

## Herbert R. Lerner

ductive, Gastro-Rena

Section 4 - Indications for Use

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