FDA.reportPublic FDA data

LIVING ENRICHMENT

Primary DI
16970729042005
Brand
LIVING ENRICHMENT
Company
Zhongshan Transtek Electronics Co.,Ltd
Model
TF-4002
Published
2022-05-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
16970729042005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1697072904200516970729042005

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
544411562
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970729040202CADENCEGBS-2104-G2025-07-21
06970729040080TeleRPM™GBS-2104-G2025-02-06
06970729040226TeleMate Health &TeleRPMGBS-2104-G2024-04-08
06970729040165EZFASTGBF-2108-B2023-07-11
06970729040097Remotecare4UGBS-2012-B2023-04-29
06970729040103TeleRPM™GBS-2104-G2023-04-29
06970729040066Vitasigns LLCGBS-2104-G2023-01-13
16970729040001Veris HealthGBS-2012-B2022-11-29
16970729040018TeleRPM™GBS-2104-G2022-11-29
16970729040025TeleRPM™GBS-2104-G2022-11-29
16970729041084TeleRPMGBS-2012-B2022-09-13
16970729042012TranstekGBF-2008-B12022-06-22
16970729041060LIFECAREBS-2001-G12022-05-17
16970729041077SYMBOLHEALTHBS-2001-G12022-05-17
16970729041053TranstekGBS-2104-G2022-03-05
16970729041046TranstekGBS-2104-G2022-01-14
16970729041039Health Wealth SafeBS-2001-G12021-12-03
16970729041022CARDIO 1stBS-2001-G12021-09-30
16970729041015WebCareHealthBS-2001-G12021-08-20
16970729041008TranstekBS-2001-G12021-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04719846013230CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
04719846016491CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
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00810140062994RENPHOJoicom CorporationPUH2026-04-08
16977035520005ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
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16977035520029ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520036ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520043ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520050ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
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16977035520081ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
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16977035520104ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520111ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520128ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520135ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520142ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520159ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520166ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520173ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520180ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520197ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
00694501143849Health O MeterStar Elite IncPUH2026-03-25
00694501143863Health O MeterStar Elite IncPUH2026-03-25
00810140062901RENPHOJoicom CorporationPUH2026-01-04
00810140062840RENPHOJoicom CorporationPUH2025-11-25
00810140062819RENPHOJoicom CorporationPUH2025-10-24
08809209592253InBodyInBody Co., Ltd.PUH2025-10-03