FDA.reportPublic FDA data

"2"" x 2"" Rectangle Electrodes"

Primary DI
00850706007304
Brand
"2"" x 2"" Rectangle Electrodes"
Company
BIOMEDICAL LIFE SYSTEMS, INC.
Model
EERC200400M
Catalog number
EERC200400M
Device description
"BioStim 2"" x 2"" Rectangle Electrodes - 10 pouches of 4 each"
Published
2024-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
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
K042301000
K142099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042301000PROTENS ELECTRODEBio Protech, Inc.2004-09-03GXY
K142099000CUTANEOUS ELECTRODESBio Protech, Inc.2014-11-17GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850706007304PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850706007304008507060073048507060073040850706007304

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
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
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
00850706007236Bio Knit Conductive cuffGAR888GAR8882020-03-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
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