FDA.reportPublic FDA data

efuy

Primary DI
06947468544575
Brand
efuy
Company
Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
Model
T9143
Published
2017-09-04
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
K122976000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122976000BODY FAT SCALE MODEL SF-371Shenzhen Belter Health Measurement and Analysis TE2013-01-04MNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16947468544572PackageGS11In Commercial Distribution
26947468544579PackageGS15In Commercial Distribution
06947468544575PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694746854457216947468544572
2694746854457926947468544579
06947468544575069474685445756947468544575

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
529903321
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06947468500519RITE AIDTE-972023-09-20
16947468500363RITE AIDTE-972023-09-20
06947468500502BytechT30-BEE2023-06-26
16947468500356BytechT30-BEE2023-06-26
06947468500496RITE AIDTE-972023-05-27
16947468500349RITE AIDTE-972023-05-27
06947468500489 NOTE-792023-05-23
16947468500332 NOTE-792023-05-23
06947468500441BluedotTE-792023-03-29
16947468500325BluedotTE-792023-03-29
06947468500434CARE TOUCHTE-912022-11-14
16947468500318CARE TOUCHTE-912022-11-14
06947468500403biotricityePA-13B42022-08-18
06947468500427biotricityTE-912022-08-18
16947468500295biotricityePA-13B42022-08-18
16947468500301biotricityTE-912022-08-18
06947468500397RITE AIDTE-972022-08-09
16947468500288RITE AIDTE-972022-08-09
06947468500373belterETE-107B42022-03-24
06947468500366KainkriptTE-952022-03-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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08809209590976InBodyInBody Co., Ltd.MNW2023-06-22
08809209591676InBodyInBody Co., Ltd.MNW2023-06-22
08809209591683InBodyInBody Co., Ltd.MNW2023-06-22
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