ES-BC

Primary DI
B322F0011
Brand
ES-BC
Company
LD TECHNOLOGY, LLC
Model
F001
Device description
EC-BC indication for use: Claculation and historical tracking of : Actual resistance, actual reactance, actual impedance, actual phase angle,estimated body fat mass, estimated body water,estimated intra-cellular water, estimated extra-cellular water,estimate basic metabolic rate,estimated daily energy expenditure,actual body fat mass
Published
2024-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MNWAnalyzer, Body Composition

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNWAnalyzer, Body CompositionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103026000ELECTRO SENSOR -BODY COMPOSITIONLd Technology, LLC2011-03-29MNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B322F0011PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
305-379-9900albert.ldteck@gmail.com

Regulatory Flags#

DUNS number
079443785
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B322H0011LD-EKGH0012024-03-05
B322A0011SweatCA0012019-03-12
B322B0011TM-Oxi SystemB0012019-01-16
B322E0011BP-BT Lifeprobes Kiosk E0012024-03-05
B322G0011ANS1 SoftwareG0012024-03-05
B322C0011TBL-ABIC0012019-01-16
B322D0011LD-OxyD0012019-01-16

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