FDA.reportPublic FDA data

Etekcity Smart Fitness Scale

Primary DI
10817915020071
Brand
Etekcity Smart Fitness Scale
Company
ETEKCITY CORPORATION
Model
FIT 8S
Published
2019-12-20
Public version status
New
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
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
10817915020071PackageGS18In Commercial Distribution
00817915020074PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081791502007110817915020071
00817915020074008179150200748179150200740817915020074

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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817915020262Etekcity Smart Fitness ScaleEFS-C651-WUS2025-07-01
10817915020255Etekcity Neck Massager Heated ProENM-C221-WUS2025-03-31
10817915020231EtekcityEFS-C671-WUST2025-01-14
10817915020217EtekcityEFS-A591S-KUST2024-11-04
10817915020194EtekcityEFS-E661-WUS2024-08-24
10817915020200EtekcityEFS-E661-KUS2024-08-24
10817915023218Etekcity Smart Fitness ScaleESF932024-03-22
10817915029159Etekcity Blood Pressure MonitorEBP-M071S-WUS2022-11-07
10817915028213Etekcity Smart Fitness ScaleEFS-A591S-WUST2021-08-24
10817915028220Etekcity Smart Fitness ScaleEFS-A591S-KUST2021-08-24
10817915028237Etekcity Smart Fitness ScaleEFS-A591S-WUSR2021-08-24
10817915028244Etekcity Smart Fitness ScaleEFS-A591S-KUSR2021-08-24
10817915020187Etekcity Smart Fitness ScaleESF-5512021-05-31
10817915020163Etekcity Smart Fitness ScaleESF14, ESF382020-08-01
10817915020064Etekcity Smart Fitness ScaleESF932019-10-10
20817915020047ETEKCITY TENS Unit Electrode Pads(50x50mm)ETU-P122019-09-20
20817915020054ETEKCITY TENS Unit Electrode Pads(50x100mm)ETU-P122019-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04012030024921seca analytics 125seca GmbH & Co. KGPUH2026-06-02
06932825306118TeleRPMGuangdong Transtek Medical Electronics Co.,LtdPUH2026-05-29
06932825306125PulseGuangdong Transtek Medical Electronics Co.,LtdPUH2026-05-29
04719846013230CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
04719846016491CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
00810140063007RENPHOJoicom CorporationPUH2026-04-20
00810140062994RENPHOJoicom CorporationPUH2026-04-08
16977035520005ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520012ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
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
16977035520067ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520074ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520081ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520098ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
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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