FDA.reportPublic FDA data

FlowKeepers Gel Pads

Primary DI
00860012717613
Brand
FlowKeepers Gel Pads
Company
KRENERB
Model
Gel Pad Envelope
Device description
Gel pad envelope with 2 packs of 2 gel pads each, Total of 4 gel packs
Published
2025-12-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K131720000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K131720000HIVOX SELF ADHESIVE ELECTRODE GEL PADSHivox Biotek, Inc.2014-07-25GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860012717610PackageGS12In Commercial Distribution
00860012717613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001271761010860012717610
00860012717613008600127176138600127176130860012717613

GMDN Terms#

Term, Definition table
TermDefinition
Electrode conductive skin pad, reusableA noninvasive conductive material designed to facilitate electrical conduction between an external electrode (e.g., transcutaneous electrical stimulation electrode) and the skin surface. It is typically in the form of a gel pad/patch designed to adhere the electrode (not included) to the skin surface. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area2.3Square centimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3023885016info@flowkeepers.com

Regulatory Flags#

DUNS number
144867619
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860012717637FlowKeepersEP-201 Pro Bundle2025-11-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08682250582035Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
08682250582042Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
08682250582059Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-10-27
10816312029427Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-10-27
00817717023105SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00817717023112SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00817717023129SENSADERM BLUEVision Quest Industries IncorporatedGXY2026-10-23
00817717023136SENSADERMVision Quest Industries IncorporatedGXY2026-10-23
00851913006296UltraStim Wire FoamAXELGAARD MANUFACTURING CO., LTD.GXY2026-10-21
00382830063821NatusXLTEKGXY2026-10-15
00382830063838NatusXLTEKGXY2026-10-15
00382830063845NatusXLTEKGXY2026-10-15
00382830063852NatusXLTEKGXY2026-10-15
00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731112Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
06973602731129Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
00850080988718AUVONUAN HEALTHCARE LIMITEDGXY2026-10-08
00810200390265KSK.S. CHOI, CORPORATIONGXY2026-09-22
00810200390272AcuZoneK.S. CHOI, CORPORATIONGXY2026-09-22
00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07