FDA.reportPublic FDA data

belter

Primary DI
26947468500384
Brand
belter
Company
Shenzhen Belter Health Measurement and Analysis Technology Co., Ltd.
Model
SF-371
Published
2017-01-09
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

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
16947468500387PackageGS11In Commercial Distribution
26947468500384PackageGS15In Commercial Distribution
06947468500380PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1694746850038716947468500387
2694746850038426947468500384
06947468500380069474685003806947468500380

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

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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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
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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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00074108278043Conair CONAIR CORPORATIONMNW2022-12-05
00074108313874CONAIRCONAIR CORPORATIONMNW2022-11-28
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