FDA.reportPublic FDA data

Headbox Safety Ribbon Cable for Cap Connection

Primary DI
08592566639210
Brand
Headbox Safety Ribbon Cable for Cap Connection
Company
DEYMED Diagnostic s.r.o.
Model
100 cm
Catalog number
63-921
Device description
Neurofeedback device accessories
Published
2023-06-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HCCDevice, Biofeedback

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCCDevice, BiofeedbackNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08592566639210PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592566639210085925666392108592566639210

GMDN Terms#

Term, Definition table
TermDefinition
Psychophysiological biofeedback systemA computerized device assembly designed for analysis and real-time feedback (biofeedback) of a variety of physiological parameters [e.g., heart rate, respiration, skin conductance, skin temperature, range of motion, force output, electroencephalography (EEG), electromyography (EMG), electrocardiography (ECG) data] to assist a patient in developing a degree of conscious control over typically involuntary functions, usually for relaxation training and muscle re-education. It includes multiple pieces of patient monitoring hardware (e.g., electrodes, sensors), computer interface devices, and dedicated software; it is intended to be used with an off-the-shelf computer.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-375-8353sales@ronanmedical.com

Regulatory Flags#

DUNS number
495566056
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08592566001093Pair of Ear Electrodes Sn (Tin)white, 1.5 m00-1092023-06-12
08592566001109Pair of Ear Electrodes Sn (Tin)white, 15 cm00-1102023-06-12
08592566001116Pair of Ear Electrodes Sn (Tin)blue, 1.5 m00-1112023-06-12
08592566001208Disposable blunted needles50 pcs00-1202023-10-26
08592566419003TruScan Neurofeedback Adapter41-90041-9002023-10-26
08592566431395TruScan LT 24 Neurofeedback headbox43-13943-1392023-10-26
08592566432392TruScan LT 32 Neurofeedback headbox43-23943-2392023-10-26
08592566449000TruScan Neurofeedback optical cable V3.3L44-90044-9002023-10-26
08592566453618Deymed Li-ion Battery3.7V 2500mAh 1665045-3612023-10-26
08592566509001TruScan Neurofeedback Acquisition50-90050-9002023-10-26
08592566509506TruScan Neurofeedback Explorer50-95050-9502023-10-26
08592566639005Ear Electrode Sn (Tin)white, 1.5 m63-9002023-10-26
08592566639012Ear Electrode Sn (Tin)white, 15 cm63-9012023-10-26
08592566639029Ear Electrode Sn (Tin)blue, 1.5 m63-9022023-10-26
08592566639234Headbox Safety Ribbon Cable for Cap Connection50cm63-9232023-10-26
08592566639340EEG cap strapXS (green)63-9342023-10-26
08592566639357EEG cap strapS (yellow)63-9352023-10-26
08592566639364EEG cap strapM (red)63-9362023-10-26
08592566639371EEG cap strapL (blue)63-9372023-10-26
08592566679001FlexiCAP electrode ring - rubberwhite67-9002023-10-26

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04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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04560340091817Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
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00816271020407UltiumNoraxon U.S.A., Inc.HCC2026-03-30
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00816271020766UltiumNoraxon U.S.A., Inc.HCC2026-03-30
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