FDA.reportPublic FDA data

SENSADERM

Primary DI
00817717023112
Brand
SENSADERM
Company
Vision Quest Industries Incorporated
Model
51-60029-001
Device description
ELECTRODE 2 PAIR 2.9" ROUND
Published
2026-10-23
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
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
K001117000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K001117000COMFORT STIMR & D Medical Products, Inc.2000-07-05GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817717023112PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817717023112008177170231128177170231120817717023112

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, reusableAn 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 reusable device.

Contacts#

Phone, Email table
PhoneEmail
800-266-6969info@vqorthocare.com

Regulatory Flags#

DUNS number
791122422
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00817717023105SENSADERM51-60020-0042026-10-23
00817717023129SENSADERM BLUE51-60020-0022026-10-23
00817717023136SENSADERM51-60020-0032026-10-23
00817717023099VQ OrthoCarePL-029K26-VQ2024-03-28
00817717020456VQ ORTHOCARE08-22006-0012022-03-21
00817717020463VQ ORTHOCARE08-22006-0022022-03-19
00817717020470VQ ORTHOCARE08-22996-0012022-03-19
00817717020487VQ ORTHOCARE08-22996-0022022-03-19
00817717020494VQ ORTHOCARE08-22008-0012022-03-19
00817717020500VQ ORTHOCARE08-22008-0022022-03-19
00817717020517VQ ORTHOCARE08-22998-0012022-03-19
00817717020524VQ ORTHOCARE08-22998-0022022-03-19
00817717020531VQ ORTHOCARE08-32006-0012022-03-19
00817717020548VQ ORTHOCARE08-32006-0022022-03-19
00817717020555VQ ORTHOCARE08-32996-0012022-03-19
00817717020562VQ ORTHOCARE08-32996-0022022-03-19
00817717020579VQ ORTHOCARE08-32008-0012022-03-19
00817717020586VQ ORTHOCARE08-32008-0022022-03-19
00817717020593VQ ORTHOCARE08-32998-0012022-03-19
00817717020609VQ ORTHOCARE08-32998-0022022-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817717023105SENSADERMVision 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
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22