TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER

K102191 · Zhongshan Transtek Electronics Co., Ltd. · MNW · May 2, 2011 · Cardiovascular

Device Facts

• Record ID: K102191
• Device Name: TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZER
• Applicant: Zhongshan Transtek Electronics Co., Ltd.
• Product Code: MNW · Cardiovascular
• Decision Date: May 2, 2011
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 870.2770
• Device Class: Class 2

Indications for Use

The Transtek Glass Body 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

Transtek Glass Body Analyzer (models GBF-830, GBF-835, GBF-950, SA-15) uses foot-to-foot bioelectrical impedance analysis (BIA) to estimate body composition. Device inputs: electrical current (50 kHz) passed through body via glass and stainless steel pads on platform. Device outputs: weight, body fat mass, total body water, bone mass, muscle mass. Used in home/domestic setting by adults 18+; operator is the user. Data stored for 8-10 users. Device also functions as conventional scale. Output displayed to user for health/fitness monitoring.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

BIA technology; 50 kHz operating frequency; 4 electrodes; glass and stainless steel contact pads; battery-powered (AAA, AA, or CR2032 depending on model); standalone operation; stores data for 8-10 users.

Indications for Use

Indicated for generally healthy adults 18 years of age or older for measurement of weight and estimation of body fat, total body water percentage, bone mass, and muscle mass. 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

• Scaleman Body Fat Scales, Model FS-148BW1 (K083838)

Submission Summary (Full Text)

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K102191
PAGE 1 OF 4

#### WE INSPIRE · WE DELIVER

# Section 5 - 510(k) Summary

- 2 2011

Date of Summary Preparation: 11/22/2010

#### 1. Submitter's Identifications

Submitter's Name: ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. Address: Jin'an Road, Minzhong, Zhongshan City, Guangdong, China Contact Person: Gorden Guo Contact Email Address: [e-mail] Telephone: [phone] ext. 231 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] ext. 8

#### 3. Name of the Device

Device Classification Name: Analyzer, Body Composition (Impedance Plethysmograph) Product Name: TRANSTEK Glass Body Analyzer Trade Name: Transtek Models: GBF-830, GBF-835, GBF-950, SA-15 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

Fook Tin, Scaleman Body Fat Scales, Model FS-148BW1, K083838

#### 5. Device Description

The TRANSTEK Glass Body Analyzer uses BIA (Bio Impedance Analysis) technology which passes an electrical current through the body to estimate body fat mass, total body water and bone

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mass. The electrical current is small and may not be felt. Contact with the body is made via glass and stainless steel pads on the platform of the analyzer.

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

This scale stores the personal data of up to 8 or 10 users. As well as being an analyzer, this device can be used as a conventional scale.

#### 6. Intended Use of Device

The Transtek Glass Body 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.

#### 7. Summary of Substantial Equivalence

Table 1: The difference between TRANSTEK Glass Body Analyzer and the predicate device, Scaleman Body Fat Scales (Model FS-148BW1)

| Feature | Proposed Device:<br>TRANSTEK Glass Body Analyzer<br>Models: GBF-830, GBF-835<br>GBF-950, SA-15 | Predicate Device:<br>Scaleman Body Fat Scales<br>Model: FS-148BW1 | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) Number | K102191 | K083838 | |
| Manufacturer | ZHONGSHAN TRANSTEK<br>ELECTRONICS CO., LTD | Fook Tin Technologies Ltd. | |
| Classification | 21 CFR 870.2770 | 21 CFR 870.2770 | |
| Product Code | MNW | MNW | |
| Indication for use | The Transtek Glass Body Analyzer<br>measure weight and uses<br>bioelectrical impedance analysis<br>(BIA) technology to estimate body<br>fat, total body water percentage,<br>bone mass, and muscle mass in<br>generally healthy adults 18 years of<br>age or older. It is intended for use in<br>the home/domestic setting only. | The Scaleman Body Fat Scales-<br>Models in "Family Model List 1A"<br>is a series of body composition<br>analyzers that measure body weight<br>and impedance and estimate<br>percentage of body fat and body<br>water using BIA (bioelectrical<br>impedance analysis). They are<br>intended for use by healthy children<br>10-17 years old and healthy adults<br>with active moderately active to | |
| TRANSTEK | | K102191<br>PAGE 3 OF 4 | |
| | mass, muscle mass and body fat<br>simultaneously, thus giving you a<br>more accurate reading of your<br>overall health and fitness.<br>It is not intended for use by pregnant<br>women or children under the age of<br>18. | healthy children 10-17 years old<br>and healthy adults with active,<br>moderately active, to inactive<br>lifestyles for body composition<br>assessment in the home<br>environment. | |
| | | The Scaleman Body Fat Scales -<br>Models in 'Family Model List 1B' is<br>a series of body composition<br>analyzers that measure body<br>weight and impedance and<br>estimate percentage of body fat<br>and body water, bone mass and<br>muscle mass using BIA<br>(bioelectrical impedance analysis).<br>They are intended for use by<br>healthy children 10-17 years old<br>and healthy adults with active,<br>moderately active, to inactive<br>lifestyles for body composition<br>assessment in the home<br>environment. | |
| Device<br>description | TRANSTEK Glass Body Analyzer<br>utilizes a "foot-to-foot" bioelectrical<br>impedance analysis (BIA)<br>technology to determine internal<br>body composition. | Scaleman Body composition<br>analyzer/scale that utilizes a<br>"foot-to-foot" bioelectrical<br>impedance (BIA) technology to<br>determine internal body<br>composition. | |
| Analysis<br>method | BIA<br>(Bioelectrical Impedance Analysis) | BIA | |
| Operating<br>parameters | 50 KHz | 50 KHz | |
| Power<br>source | GBF-830, 4*AAA<br>GBF-835, 2*CR2032<br>GBF-950, 4*AAA<br>SA-15, 2*AA | Replaceable 9V or CR2032 or AAA<br>batteries, depending on the model. | |
| Operating<br>keys | GBF-830, GBF-835, GBF-950 (4),<br>SA-15 (3) | Range of 3 to 6, depending on the<br>model | |
| Number of<br>electrodes | 4 | 4 or 2 | |

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Section 5 - 510(k) Summary

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Page 3 of 4

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# TRANSTEK

## 8. Conclusions

The subject devices have all features of the predicate device, Scaleman Body Fat Scales (Model FS-148BW1) except the new features and the power source voltage of the device. These differences do not affect the safety and effectiveness of the subject devices : BIA (Bioelectrical Impedance Analysis) technology is same as what is used in Scaleman Body Fat Scales (Model FS-148BW1). Thus, the subject devices are substantially

equivalent to the predicate devices.

--- End of this Section ---

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# 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 stylized eagle or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G60 Silver Spring, MD 20993-0002

ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. c/o Mr. Leo Wang Consulting Manager A03 Lab of BTS No. 1 Fanghua Street, Hi-tech District Chengdu Sichuan 610041 CHINA

MAY - 2 2011

: Re: K102191

Trade/Device Name: TRANSTEK GLASS BODY ANALYZER Models: GBF-830, GBF-835, GBF-950, SA-15 Regulation Number: 21 CFR \$870.2770 Regulation Name: Impedance plethysmograph Regulatory Class: II Product Code: MNW Dated: April 8, 2011 Received: April 19, 2011

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.

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 of medical device-related

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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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Michael Lemur MD

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# WE INSPIRE · WE DELIVER

# Section 4 - Indications for Use

510(k) Number (if known): K102191

Device Name:

TRANSTEK GLASS BODY ANALYZER Models:GBF-830, GBF-835,GBF-950,SA-15

Indications for Use:

The Transtek Glass Body 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)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

ORH Office of Device