FDA.reportPublic FDA data

Transtek

Primary DI
14714781444665
Brand
Transtek
Company
ADAM ELEMENTS INTERNATIONAL CO., LTD.
Model
LS202-B
Device description
Body Fat Analyzer
Published
2017-01-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
MNWAnalyzer, Body Composition

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNWAnalyzer, Body CompositionCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14714781444665PackageGS11In Commercial Distribution
24714781444662PackageGS15In Commercial Distribution
04714781444668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1471478144466514714781444665
2471478144466224714781444662
04714781444668047147814446684714781444668

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical body composition analyserAn electronic device designed to estimate body composition (i.e., percent body fat, lean, bone, and/or hydration) with regards to bioelectrical impedance analysis (BIA) and often personal characteristics (e.g., age, gender, height, weight). It may be in the form of a unit with electrodes applied to the surface of the patient’s body, or a scale(s) placed on the floor and upon which the patient stands to measure total body weight. Both types perform BIA by passing a low electrical current through the body; personal characteristics may be manually entered. Data are analysed to provide measurements that may include body mass index (BMI), fat/muscle/bone mass, and total body water percent.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658869195
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04714781444668TranstekLS202-B2017-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04904785198449Body Composition AnalyzerTANITA CORPORATIONMNW2025-10-24
04904785230491Body Composition AnalyzerTANITA CORPORATIONMNW2025-10-24
08809209592260InBodyInBody Co., Ltd.MNW2025-10-03
08809209592277InBodyInBody Co., Ltd.MNW2025-10-03
00077784049198TAYLORTAYLOR PRECISION PRODUCTS, INC.MNW2025-05-06
20077784049192TAYLORTAYLOR PRECISION PRODUCTS, INC.MNW2025-05-06
08809209590969InBodyInBody Co., Ltd.MNW2024-07-23
00074108499714ConairCONAIR CORPORATIONMNW2024-05-13
B322F0011ES-BC LD TECHNOLOGY, LLCMNW2024-03-05
00875011004121Weight GurusGreater GoodsMNW2024-02-22
00074108356581CONAIRCONAIR CORPORATIONMNW2024-01-15
00074108451200CONAIRCONAIR CORPORATIONMNW2023-07-17
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00074108458995CONAIRCONAIR CORPORATIONMNW2023-07-17
00074108483553CONAIRCONAIR CORPORATIONMNW2023-06-24
08809209590976InBodyInBody Co., Ltd.MNW2023-06-22
08809209591676InBodyInBody Co., Ltd.MNW2023-06-22
08809209591683InBodyInBody Co., Ltd.MNW2023-06-22
00074108087799CONAIRCONAIR CORPORATIONMNW2023-04-30
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00074108317216CONAIRCONAIR CORPORATIONMNW2023-04-30
00074108333025CONAIRCONAIR CORPORATIONMNW2023-04-30
00694501121786SunbeamStar Elite IncMNW2023-01-17
00074108278043Conair CONAIR CORPORATIONMNW2022-12-05
00074108313874CONAIRCONAIR CORPORATIONMNW2022-11-28
00074108468451CONAIRCONAIR CORPORATIONMNW2022-07-28