FDA.reportPublic FDA data

RJL Quantum

Primary DI
B202Q40
Brand
RJL Quantum
Company
R.J.L. SCIENCES, INC.
Model
Quantum-IV
Catalog number
Q4
Published
2017-02-01
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
B202Q40PrimaryHIBCC0

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
586-790-0200cs@rjlsystems.com
1-800-528-4513cs@rjlsystems.com

Regulatory Flags#

DUNS number
021842273
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B202SC6PIN100BIA Subject Cables6-Pin Subject Cables (10 ft)SC6PIN102018-04-24
B202SC6PIN60BIA Subject Cables6-Pin Subject Cables (6 ft)SC6PIN62018-04-24
B202SC6PIN80BIA Subject Cables6-Pin Subject Cables (8 ft)SC6PIN82018-04-24
B202SCLEM60BIA Subject CablesLEMO Subject Cables (6 ft)SCLEM62018-04-24
B202Q70RJL QuantumQuantum 7Q72023-08-22
B202QL0RJL QuantumQuantum LegacyQL2019-08-06
B202BC0BCBC (Body Composition Software)BC2017-08-10
B202BCSEG0BCBC (Body Composition Software) SegmentalBCSEG2017-08-10
B202Q20RJL QuantumQuantum-IIQ22017-02-01
B202Q30RJL QuantumQuantum-IIIQ32017-02-01
B202Q50RJL QuantumQuantum-VQ52017-02-01
B202Q5S0RJL QuantumQuantum-V SegmentalQ5S2017-02-01
B202QDT0RJL QuantumQuantum DesktopQDT2017-02-01
B202QX0RJL QuantumQuantum-XQX2017-02-01
B202925001BIA Electrodes9250092500P2017-02-01
B202925004BIA Electrodes9250092500P2017-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04719846016491CharderCHARDER ELECTRONIC CO., LTD.PUH2026-04-29
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