FDA.reportPublic FDA data

BC

Primary DI
B202BC0
Brand
BC
Company
R.J.L. SCIENCES, INC.
Model
BC (Body Composition Software)
Catalog number
BC
Published
2017-08-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

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
B202BC0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bioelectrical signal analysis softwareA software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021842273
Device count
1
Premarket exempt
true
Lot or batch
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
B202BCSEG0BCBC (Body Composition Software) SegmentalBCSEG2017-08-10
B202Q20RJL QuantumQuantum-IIQ22017-02-01
B202Q30RJL QuantumQuantum-IIIQ32017-02-01
B202Q40RJL QuantumQuantum-IVQ42017-02-01
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
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
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