FDA.reportPublic FDA data

"BioKnit Back Brace 7"" Conductive Garment - Kit"

Primary DI
00857771003385
Brand
"BioKnit Back Brace 7"" Conductive Garment - Kit"
Company
BIOMEDICAL LIFE SYSTEMS, INC.
Model
KB0918423
Catalog number
KB0918423-PAD230
Device description
"Back Brace 7"" Conductive Garment with 4- 2x3 Electrodes"
Published
2022-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K053214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K053214000THERAKNIT GARMENT ELECTRODENeurotron Medical2005-12-20GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857771003385PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857771003385008577710033858577710033850857771003385

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, single-useAn electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation (EMS), cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
116956807
Device count
1
Combination product
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857771003590"2"" x 2"" pigtail electrode "EERC200MEERC200M2024-08-26
20857771003594"2"" x 2"" pigtail electrode"EERC200MEERC200M2024-08-26
10857771003597"2"" x 2"" pigtail electrode - Inner Box "EERC200MEERC200M2024-08-19
00857771003897"OUT OF USE - 2"" x 2"" pigtail electrode "OUT OF USE - EERC200MEERC200M - UDI OUT OF USE2016-09-23
00857771003941"OUT OF USE - 2"" x 2"" pigtail electrode"OUT OF USE- EERC200MEERC200M - UDI OUT OF USE2016-09-23
00857771003002"2"" x 2"" pitail electrode"EERC200MEERC200M2016-09-23
00850706007304"2"" x 2"" Rectangle Electrodes"EERC200400MEERC200400M2024-08-07
00857771003422Impulse TENS D5D5KIMTD52024-08-07
00857771003125Impulse TENS D5D5KIMTD52016-09-23
00857771003996BioMed Revived IIBRVE2BRVE22019-09-20
00857771003170EMS2000EMS2000KEMS2016-09-23
00857771003187Impulse EMS D7D7KIMD72016-09-23
00857771003194GV 350GV 350KGV2016-09-23
00857771003200BioStim NMS 2NMS 2KBSNMS22016-09-23
00857771003231QuadStar IIQuadStar IIKQST2016-09-23
00857771003255QuadStar EliteQuad Star EliteKQSE2016-09-23
00857771003965BioMed RevivedRevivedBRVE2016-11-11
00857771003972BioMed FitBioMed Fit KBMFKBMF2018-03-26
00857771003347BioKnit conductive sock - universal fitGAR122GAR1222021-05-05
00850706007298BioKnit Conductive KNEEGAR130GAR1302020-04-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02