FDA.reportPublic FDA data

"Self-Adhesive Electrode 2"" x 2"" Pro Pulse HD"

Primary DI
B243PSSA2X2PP4
Brand
"Self-Adhesive Electrode 2"" x 2"" Pro Pulse HD"
Company
ELECTRO MEDICAL TECHNOLOGIES, LLC
Model
0
Device description
Self-Adhesive Electrode
Published
2016-09-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K130987000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130987000VALUTRODE NEUROSTIMLATION ELECTRODESAxelgaard Mfg. Co., Ltd.2013-07-17GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B243PSSA2X2PP4PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile 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, 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-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
160641309
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B243PSRCR2102"Carbon-Rubber Electrodes (8"" x 3"")"02016-09-24
B243PSSA2X4PP4"Self-Adhesive Electrode 2"" x 4"" Pro Pulse HD"02016-09-23
00861284002605WellnessPro2010 Plus2010 Plus2018-06-23
00861284002636"Carbon Rubber Electrode (4"" cylinder)"02021-07-15
B243PSRCR552"Carbon-Rubber Electrodes (2"" Round)"02016-09-24
00861284002612"Carbon-Rubber Electrodes (2"" Round)"02018-06-28
00861284002629"Carbon-Rubber Electrodes (8"" x 3"")"8 x 32018-07-03
B243SSWP2010PLUS0WELLNESSPRO2010 PLUS2016-07-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
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08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
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08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
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00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
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