(272 days)
Not Found
No
The summary describes standard bioelectrical impedance analysis (BIA) technology and does not mention any AI or ML components.
No
The device measures body composition parameters but does not state any therapeutic function or intent to treat, prevent, or mitigate any disease or condition. It is for "estimating" health parameters in "generally healthy adults".
No
The device measures body composition parameters like body fat, total body water percentage, bone mass, and muscle mass to provide a reading of overall health and fitness. It does not diagnose diseases or medical conditions.
No
The device description explicitly states it uses "glass and stainless steel pads on the platform of the analyzer" for contact with the body, indicating it includes 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: The Transtek Glass Body Analyzer measures physical characteristics (weight, body composition) using bioelectrical impedance analysis. It does not analyze biological samples taken from the body.
- Intended Use: The intended use is for estimating body composition in generally healthy adults for personal health and fitness monitoring in a home setting. This is not a diagnostic purpose.
Therefore, the device falls outside the scope of an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes
MNW
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 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.
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/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)
Not Found
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
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: gzp@transtek.cn Telephone: 086-760-88282982 ext. 231 Fax: 086-760-85339231
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: leo.w@hibts.com Telephone: 086-28-86083300 Fax: 086-4006070050 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
1
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:
TRANSTEK Glass Body Analyzer
Models: GBF-830, GBF-835
GBF-950, SA-15 | Predicate Device:
Scaleman Body Fat Scales
Model: FS-148BW1 | |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 510(k) Number | K102191 | K083838 | |
| Manufacturer | ZHONGSHAN TRANSTEK
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
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. | The Scaleman Body Fat Scales-
Models in "Family Model List 1A"
is a series of body composition
analyzers that measure body weight
and impedance and estimate
percentage of body fat and body
water using BIA (bioelectrical
impedance analysis). They are
intended for use by healthy children
10-17 years old and healthy adults
with active moderately active to | |
| TRANSTEK | | K102191
PAGE 3 OF 4 | |
| | mass, muscle mass and body fat
simultaneously, thus giving you a
more accurate reading of your
overall health and fitness.
It is not intended for use by pregnant
women or children under the age of
18. | healthy children 10-17 years old
and healthy adults with active,
moderately active, to inactive
lifestyles for body composition
assessment in the home
environment. | |
| | | The Scaleman Body Fat Scales -
Models in 'Family Model List 1B' is
a series of body composition
analyzers that measure body
weight and impedance and
estimate percentage of body fat
and body water, bone mass and
muscle mass using BIA
(bioelectrical impedance analysis).
They are intended for use by
healthy children 10-17 years old
and healthy adults with active,
moderately active, to inactive
lifestyles for body composition
assessment in the home
environment. | |
| Device
description | TRANSTEK Glass Body Analyzer
utilizes a "foot-to-foot" bioelectrical
impedance analysis (BIA)
technology to determine internal
body composition. | Scaleman Body composition
analyzer/scale that utilizes a
"foot-to-foot" bioelectrical
impedance (BIA) technology to
determine internal body
composition. | |
| Analysis
method | BIA
(Bioelectrical Impedance Analysis) | BIA | |
| Operating
parameters | 50 KHz | 50 KHz | |
| Power
source | GBF-830, 4AAA
GBF-835, 2CR2032
GBF-950, 4AAA
SA-15, 2AA | Replaceable 9V or CR2032 or AAA
batteries, depending on the model. | |
| Operating
keys | GBF-830, GBF-835, GBF-950 (4),
SA-15 (3) | Range of 3 to 6, depending on the
model | |
| Number of
electrodes | 4 | 4 or 2 | |
2
Section 5 - 510(k) Summary
.
Page 3 of 4
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3
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 ---
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 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
5
Page 2
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,
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
6
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