FDA.reportPublic FDA data

Escali

Primary DI
00854202006502
Brand
Escali
Company
ESCALI CORP
Model
BFBW180
Device description
Digital Body Fat/Water Scale, Retail Packaging
Published
2019-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00854202006519PackageGS14In Commercial Distribution
00854202006502PrimaryGS10
00854202006526Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854202006519008542020065198542020065190854202006519
00854202006502008542020065028542020065020854202006502
00854202006526008542020065268542020065260854202006526

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.

Regulatory Flags#

DUNS number
072924579
Device count
1000
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854202006519EscaliBFBW1802019-11-27
00857817000880EscaliUSHM180G2017-03-23

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
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
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