FDA.report

Etekcity Smart Fitness Scale

Primary DI
10817915020101
Brand
Etekcity Smart Fitness Scale
Company
Vesync (US) Corporation
Model
ESF18
Published
2020-06-01
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

Related Records

Product Codes

CodeName
PUHAnalyzer, Body Composition, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PUHAnalyzer, Body Composition, ExemptCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10817915020101PackageGS16In Commercial Distribution
00817915020104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1081791502010110817915020101
00817915020104008179150201048179150201040817915020104

GMDN Terms

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

Regulatory Flags

DUNS number
079578783
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00817915020081Etekcity Smart Fitness ScaleESF00+2020-06-01
10817915020095Etekcity Smart Fitness ScaleESF172020-06-01
10817915020118Etekcity Smart Fitness ScaleESF242020-06-01
10817915020125Etekcity Smart Fitness ScaleESF282020-06-01
10817915020132Etekcity Smart Fitness ScaleESF372020-06-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08809209592321InBodyInBody Co., Ltd.PUH2026-02-28
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00810079250059Teladoc Health, Inc.Teladoc Health, Inc.PUH2026-02-17
10810140062908RENPHOJoicom CorporationPUH2026-01-04
00050428005804CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPUH2025-12-10
10810140062847RENPHOJoicom CorporationPUH2025-11-25
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14719846016504CharderCHARDER ELECTRONIC CO., LTD.PUH2025-08-12
04719846016484CharderCHARDER ELECTRONIC CO., LTD.PUH2025-08-11
04719846016088CharderCHARDER ELECTRONIC CO., LTD.PUH2025-08-07
08805116000645ACCUNIQSELVAS Healthcare, Inc.PUH2025-07-25
10810140062571RENPHOJoicom CorporationPUH2025-07-22
10810140062557RENPHOJoicom CorporationPUH2025-06-26
10810140062519RENPHOJoicom CorporationPUH2025-06-12
04012030022026seca mBCA 545seca GmbH & Co. KGPUH2025-05-01
04012030022033seca mBCA 542seca GmbH & Co. KGPUH2025-05-01
04012030022910seca analytics 125seca GmbH & Co. KGPUH2025-04-30
16928081771378arboleafShenzhen Yolanda Technology Co.,Ltd.PUH2025-04-14
16928081771361arboleafShenzhen Yolanda Technology Co.,Ltd.PUH2025-04-13
10810140062403RENPHOJoicom CorporationPUH2025-03-11
10810140062410RENPHOJoicom CorporationPUH2025-03-11
10810140062335RENPHOJoicom CorporationPUH2025-02-21
00031262115874HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115898HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115904HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115911HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115959HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115966HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115997HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262116000HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25