FDA.reportPublic FDA data

Amazfit Balance

Primary DI
06972596107415
Brand
Amazfit Balance
Company
Anhui Huami Information Technology Co., Ltd.
Model
A2287
Published
2023-08-14
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
06972596107415PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972596107415069725961074156972596107415

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
421368652
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
00850051482931Zepp Clarity Tulip Dome A2316Y2023-11-28
00850051482948Zepp Clarity Open Dome SA2317Y2023-11-28
00850051482955Zepp Clarity Open Dome MA2318Y2023-11-28
00850051482962Zepp Clarity Open Dome LA2319Y2023-11-28
00850051482979Zepp Clarity Closed Dome SA231AY2023-11-28
00850051482986Zepp Clarity Closed Dome MA231BY2023-11-28
00850051482993Zepp Clarity Closed Dome LA231CY2023-11-28
00850058994000Zepp Clarity OmniA23172023-11-28
00850058994017Zepp Clarity RIC Wire Size 1 LeftA231DY2023-11-28
00850058994024Zepp Clarity RIC Wire Size 1 RightA231EY2023-11-28
00850058994031Zepp Clarity RIC Wire Size 2 LeftA231FY2023-11-28
00850058994048Zepp Clarity RIC Wire Size 2 RightA2320Y2023-11-28
00850058994055Zepp Clarity RIC Wire Size 3 LeftA2321Y2023-11-28
00850058994062Zepp Clarity RIC Wire Size 3 RightA2322Y2023-11-28
00850051482832Zepp Clarity OmniA23172023-11-27
00850051482306Zepp Clarity PixieA22852023-08-16
00850051482313Zepp Clarity Pixie Open Dome SA2310Y2023-08-16
00850051482320Zepp Clarity Pixie Open Dome MA2311Y2023-08-16
00850051482337Zepp Clarity Pixie Closed Dome SA2312Y2023-08-16
00850051482344Zepp Clarity Pixie Closed Dome MA2313Y2023-08-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810140063137FitindexJoicom CorporationPUH2026-08-18
00810140063151FitindexJoicom CorporationPUH2026-08-18
00810140063168RENPHOJoicom CorporationPUH2026-08-18
00073796237509VIVA 360+ Smart ScaleOmron Healthcare, Inc.PUH2026-06-16
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
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