FDA.reportPublic FDA data

Pro Advantage

Primary DI
M220P6408539
Brand
Pro Advantage
Company
NATIONAL DISTRIBUTION & CONTRACTING, INC.
Model
P640853
Catalog number
P640853
Device description
Pro Advantage Electrode 3Round Cloth
Published
2017-02-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K042301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042301000PROTENS ELECTRODEBio Protech, Inc.2004-09-03GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M220P640853PackageHIBCC400
M220P6408532PackageHIBCC40
M220P6408539PrimaryHIBCC0

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.

Contacts#

Phone, Email table
PhoneEmail
6153663230compliance@ndc-inc.com

Regulatory Flags#

DUNS number
009831413
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M220P3010088Pro AdvantageP301008P3010082017-02-13
M220P3011058Pro AdvantageP301105P3011052017-02-13
M220P3011158Pro AdvantageP301115P3011152017-02-13
D023Q4000418QualaQ40004Q400042017-02-13
D023Q400042ML1QualaQ400042MLQ400042ML2017-04-25
D023Q400122ML19QualaQ400122MLQ400122ML2017-10-18
D023Q4003017QualaQ40030Q400302017-02-13
D23Q4001217QualaQ40012Q400122017-02-13
M2207250003Pro Advantage72000720002025-09-11
M220761002Pro Advantage76100761002025-09-11
M220762002Pro Advantage76200762002025-09-11
M220767000Pro Advantage76700767002025-09-11
M220768001Pro Advantage76800768002025-09-11
M220768011Pro Advantage76801768012025-09-11
M220769000Pro Advantage76900769002025-09-11
M220770001Pro Advantage77000770002025-09-11
M220771001Pro Advantage77100771002025-09-11
M220720005Pro Advantage72000720002025-09-11
M220761003Pro Advantage76100761002025-09-11
M220762003Pro Advantage76200762002025-09-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
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
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378271Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378288Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378295Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378301Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378318Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378325Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378349Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378356Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378363Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378370Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378387Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08