FDA.reportPublic FDA data

FlexiCAP

Primary DI
08592566829109
Brand
FlexiCAP
Company
DEYMED Diagnostic s.r.o.
Model
Size XS 47-51 cm, 18,5-20 in, layout 06
Catalog number
82-910
Device description
82-910
Published
2023-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
08592566829109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08592566829109085925668291098592566829109

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.

Contacts#

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

Regulatory Flags#

DUNS number
495566056
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
08592566829116FlexiCAPSize S 51-55 cm, 20-21,5 in, layout 0682-9112023-10-26
08592566829123FlexiCAPSize M 55-59 cm, 21,5-23 in, layout 0682-9122023-10-26
08592566829130FlexiCAPSize L 59-63 cm, 23-25 in, layout 0682-9132023-10-26
08592566829147FlexiCAPSize XS 47-51 cm, 18,5-20 in82-9142023-10-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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04560340091756Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091763Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091770Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091787Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091794Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
04560340091800Medical HAL Lumbar TypeCYBERDYNE, INC.HCC2026-04-22
00816271020377NoraxonNoraxon U.S.A., Inc.HCC2026-03-30
00816271020407UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020414UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020421UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020438UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020445UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020452UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020469UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020476UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020483UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020490UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020506UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020513UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020520UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020735CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020766UltiumNoraxon U.S.A., Inc.HCC2026-03-30
00816271020773CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020889Ultium / CoreNoraxon U.S.A., Inc.HCC2026-03-30
00816271020896UltiumNoraxon U.S.A., Inc.HCC2026-03-30