FDA.reportPublic FDA data

A&D Medical

Primary DI
00093764604461
Brand
A&D Medical
Company
A&D COMPANY, LIMITED
Model
UC-450BLE-CV
Catalog number
UC-450BLE-CV & UC-450BLE
Device description
Wireless Body Composition Scale
Published
2024-01-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00093764604461PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00093764604461000937646044610937646044610093764604461

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-888-726-9966htn@andonline.com

Regulatory Flags#

DUNS number
691722987
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00093764604720A&D MedicalUA-1020CEL-CSUA-1020CEL-CS2026-05-08
00093764604553A&D MedicalUA-660CNUA-660CN2026-02-27
00093764604522A&D MedicalUA-810BLEUA-810BLE2025-02-19
00093764604539A&D MedicalUA-910BLEUA-910BLE2025-02-19
00093764604447A&D MedicalUA-1020CELUA-1020CEL2024-12-10
00093764604140A&D MedicalUC-356BLEUC-356BLE2024-10-18
00093764604546A&D MedicalUC-356BLE-STUC-356BLE-ST2024-10-18
00093764604454A&D MedicalUC-352CELUC-352CEL2024-10-16
00093764604492A&D MedicalUA-660UA-6602024-09-01
00093764604508A&D MedicalUA-770BLEUA-770BLE2024-09-01
00093764604515A&D MedicalUA-1040TBLEUA-1040TBLE2024-09-01
00093764603501A&D MedicalTM-2657PTM-2657P, TM-2657P-RS, TM-2657P-BT2016-09-23
00093764604133A&D MedicalUP-200UP-2002024-02-15
00093764600623A&D MedicalUA-789UA-789AC2016-09-23
00093764601576A&D MedicalUA-705UA-705V2016-09-23
00093764601583A&D MedicalUA-705UA-705VL2016-09-23
00093764602870A&D MedicalUA-1020UA-10202016-09-23
00093764602931A&D MedicalUA-1030TUA-1030T2016-09-23
00093764603341A&D MedicalUA-651UA-6512016-09-23
00093764603358A&D MedicalUB-543UB-5432016-09-23

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
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16977035520159ANOVATORWuhan Zhaike Network Technology Company, LimitedPUH2026-03-27
16977035520166ANOVATORWuhan 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