FDA.reportPublic FDA data

TPWT4-7

Primary DI
00816625020176
Brand
TPWT4-7
Company
Bio Medical Innovations
Model
TENS
Device description
"2.5"" Oval electrode patch in pouch of 4 each electrodes."
Published
2016-10-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
10816625020173PackageGS120In Commercial Distribution
30816625020177PackageGS14In Commercial Distribution
00816625020176PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081662502017310816625020173
3081662502017730816625020177
00816625020176008166250201768166250201760816625020176

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
2082635071dmcelroy@biomedical-innovations.com

Regulatory Flags#

DUNS number
173358318
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816625020015BF-2TENS2016-10-03
00816625020022BF-3TENS2016-10-03
00816625020039BF-4TENS2016-10-03
00816625020046BF-5TENS2016-10-03
00816625020053BF-6TENS2016-10-03
00816625020060BF-7TENS2016-10-03
00816625020077BF-8TENS2016-10-03
00816625020084SS-2TENS2016-10-03
00816625020091SS-3TENS2016-10-03
00816625020107SS-5TENS2016-10-03
00816625020114SS-6TENS2016-10-03
00816625020121TPWT4-2TENS2016-10-03
00816625020138TPWT4-3TENS2016-10-03
00816625020145TPWT4-4TENS2016-10-03
00816625020152TPWT4-5TENS2016-10-03
00816625020169TPWT4-6TENS2016-10-03
00816625020183TPWT4-8TENS2016-10-03
00816625020190200-11TENS2016-10-03
30816625020108SS-5TENS2016-10-03
30816625020016BF-2TENS2016-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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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
08720791378349Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378356Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
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08720791378370Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378387Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378394Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378400Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378417Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378424Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378431Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378448Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08