FDA.reportPublic FDA data

Body fat scale

Primary DI
00817746020304
Brand
Body fat scale
Company
BETTER BASICS, INC.
Model
SW-SBS500
Published
2016-11-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MNWAnalyzer, Body Composition

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNWAnalyzer, Body CompositionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102191000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102191000TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER; TRANSTEK GLASS BODY ANALYZER;TRANSTEK GLASS BODY ANALYZERZhongshan Transtek Electronics Co., Ltd.2011-05-02MNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817746020311PackageGS11In Commercial Distribution
00817746020328PackageGS16In Commercial Distribution
00817746020304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817746020311008177460203118177460203110817746020311
00817746020328008177460203288177460203280817746020328
00817746020304008177460203048177460203040817746020304

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
013029698
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817746020366Pulse MassagerMP-TENS-1102016-11-18
00817746020397Pulse MassagerMP-TENS310-US2016-11-18
00817746020915Pulse MassagerMP-TENS510-US2017-05-26
00817746021226Pulse OximeterMP-OX3002017-09-15
00817746020151Pulse oximeterMP-OX150-US2016-11-18
00817746020182Pulse oximeterMP-OX200-US2016-11-18
00817746020212Pulse oximeterMP-OX250-US2016-11-18
00817746026665Fever ThermometerMP-IRT4502017-09-15
00817746020243Fever therometerMP-TM21-US2016-11-18
00817746020274Fever therometerMP-IRT350-US2016-11-18
00817746020007blood pressure monitorMP-BPM20A-US2016-11-18
00817746020038blood pressure monitorMP-BPM50W-US2016-11-18
00817746020069blood pressure monitorMP-BPMW60-US2016-11-18
00817746020090blood pressure monitorMP-BPMA70-US2016-11-18
00817746020120blood pressure monitor MP-BPM80A-US2016-11-18
00817746021233Pulse OximeterMP-OX3002017-09-15
00817746021325Fever ThermometerMP-IRT4502017-09-15
00817746020335Body fat scaleSW-SBS7002017-01-17
00817746020342Body fat scaleSW-SBS7002017-01-17

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
00074108453457CONAIRCONAIR CORPORATIONMNW2023-07-17
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
00074108122728CONAIRCONAIR CORPORATIONMNW2023-04-30
00074108186751CONAIRCONAIR CORPORATIONMNW2023-04-30
00074108199256CONAIRCONAIR CORPORATIONMNW2023-04-30
00074108278197CONAIRCONAIR CORPORATIONMNW2023-04-30
00074108288493CONAIRCONAIR CORPORATIONMNW2023-04-30
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