FDA.report

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
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
PUHAnalyzer, Body Composition, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PUHAnalyzer, Body Composition, ExemptCardiovascular2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
B202Q40PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
586-790-0200cs@rjlsystems.com

Regulatory Flags

DUNS number
021842273
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
B202Q70RJL QuantumQuantum 7Q72023-08-22
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
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
B202925004BIA Electrodes9250092500P2017-02-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
08809209592321InBodyInBody Co., Ltd.PUH2026-02-28
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00810079250059Teladoc Health, Inc.Teladoc Health, Inc.PUH2026-02-17
10810140062908RENPHOJoicom CorporationPUH2026-01-04
00050428005804CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDPUH2025-12-10
10810140062847RENPHOJoicom CorporationPUH2025-11-25
04904785198456Body Composition AnalyzerTANITA CORPORATIONPUH2025-09-22
14719846016504CharderCHARDER ELECTRONIC CO., LTD.PUH2025-08-12
04719846016484CharderCHARDER ELECTRONIC CO., LTD.PUH2025-08-11
04719846016088CharderCHARDER ELECTRONIC CO., LTD.PUH2025-08-07
08805116000645ACCUNIQSELVAS Healthcare, Inc.PUH2025-07-25
10810140062571RENPHOJoicom CorporationPUH2025-07-22
10810140062557RENPHOJoicom CorporationPUH2025-06-26
10810140062519RENPHOJoicom CorporationPUH2025-06-12
04012030022026seca mBCA 545seca GmbH & Co. KGPUH2025-05-01
04012030022033seca mBCA 542seca GmbH & Co. KGPUH2025-05-01
04012030022910seca analytics 125seca GmbH & Co. KGPUH2025-04-30
16928081771378arboleafShenzhen Yolanda Technology Co.,Ltd.PUH2025-04-14
16928081771361arboleafShenzhen Yolanda Technology Co.,Ltd.PUH2025-04-13
10810140062403RENPHOJoicom CorporationPUH2025-03-11
10810140062410RENPHOJoicom CorporationPUH2025-03-11
10810140062335RENPHOJoicom CorporationPUH2025-02-21
00031262115874HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115898HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115904HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115911HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115959HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115966HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262115997HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25
00031262116000HomedicsFKA DISTRIBUTING CO., LLCPUH2025-01-25