FDA.reportPublic FDA data

Body Composition Scale

Primary DI
16974239700356
Brand
Body Composition Scale
Company
Guangzhou Daxin health technology Co.,Ltd
Model
GN-WA005-199
Published
2021-07-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Single use
true

Product Codes#

Code, Name table
CodeName
PUHAnalyzer, Body Composition, Exempt

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PUHAnalyzer, Body Composition, ExemptCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26974239700353PackageGS15Not in Commercial Distribution
16974239700356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2697423970035326974239700353
1697423970035616974239700356

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.

Regulatory Flags#

DUNS number
722481840
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974239700014Body Composition ScaleEF-651B42021-07-19
06974239700021Body Composition ScaleEF-654B42021-07-19
06974239700038Body Composition ScaleEF-655B42021-07-19
06974239700045Body Composition ScaleEF-670B42021-07-12
06974239700052Body Composition ScaleEF-706B42021-07-19
06974239700069Body Composition ScaleEF-802B42021-07-19
06974239700076Body Composition ScaleEF-916B42021-07-19
06974239700083Body Composition ScaleeF-706B4S2021-07-16
06974239700113Body Composition ScaleeF-804B4P2021-07-19
06974239700120BWELLeF-919B42022-07-15
06974239700137Body Composition ScaleeF-919B4S2021-07-19
06974239700144Body Composition ScaleT91402021-07-19
06974239700151Body Composition ScaleEF-803B42021-07-19
06974239700168Body Composition ScaleEF-804B42021-07-16
06974239700175Body Composition ScaleEF-805B42021-07-16
06974239700182Body Composition ScaleEF-806B42021-07-16
06974239700199Body Composition ScaleEF-807B42021-07-19
06974239700212Body Composition ScaleEF-915B42021-07-16
06974239700229Body Composition ScaleEF-917B42021-07-19
06974239700243Body Composition ScaleeF-712B42021-07-19

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Primary DI, Brand, Company table
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