FDA.reportPublic FDA data

Amazfit

Primary DI
06971828190034
Brand
Amazfit
Company
Anhui Huami Healthcare Co.,Ltd.
Model
A2003
Published
2020-09-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
16971828190055PackageGS15In Commercial Distribution
06971828190034PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697182819005516971828190055
06971828190034069718281900346971828190034

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
554418980
Device count
1
Premarket exempt
true
Serial number
true
Expiration date on label
true

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