FDA.reportPublic FDA data

TENS Electrode Set

Primary DI
00754756740016
Brand
TENS Electrode Set
Company
ESSENTIAL MEDICAL SUPPLY INC
Model
S1000E
Published
2017-04-11
Public version status
Update
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10754756740013PackageGS150In Commercial Distribution
20754756740010PackageGS18In Commercial Distribution
00754756740016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1075475674001310754756740013
2075475674001020754756740010
00754756740016007547567400167547567400160754756740016

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Contacts#

Phone, Email table
PhoneEmail
407-770-0710michael.hoepner@essentialmedicalsupply.com

Regulatory Flags#

DUNS number
189331325
Device count
1
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00754756740009Essential TENS SystemS1000 2017-04-11
00754756750008Essential Digital TENS SystemS20002017-04-11
10754756740006Essential TENS SystemS1000 2017-04-11
20754756740010TENS Electrode SetS1000E2017-04-11
10754756750005Essential Digital TENS SystemS20002017-04-11
00754756388003Endurance Standard Alternating Pressure Bubble PadD88002017-11-07
00754756390013Endurance Deluxe Alternating Pressure Pump & Pad ComboD9000C2017-11-07
00754756380007Endurance Standard Alternating Pressure PumpD80002017-11-07
00754756380014Endurance Standard Alternating Pressure Pump & Pad ComboD8000C 2017-11-07
10754756388000Endurance Standard Alternating Pressure Bubble PadD88002017-11-07
00754756388010Endurance Standard Alternating Pressure Bubble Pad w/FlapsD8800EX2017-11-07
00754756390006Endurance Deluxe Alternating Pressure PumpD90002017-11-07
10754756390010Endurance Deluxe Alternating Pressure Pump & Pad ComboD9000C2017-11-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
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
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08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
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08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
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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