FDA.reportPublic FDA data

Biowave Noninvasive Electrodes

Primary DI
00859911006102
Brand
Biowave Noninvasive Electrodes
Company
BIOWAVE CORPORATION
Model
MK78580 - BWEN03-U
Device description
Biowave Noninvasive Electrode - U-Set
Published
2016-08-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
LIHInterferential Current Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
LIHInterferential Current TherapyNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10859911006109PackageGS15In Commercial Distribution
20859911006106PackageGS1100In Commercial Distribution
00859911006102PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085991100610910859911006109
2085991100610620859911006106
00859911006102008599110061028599110061020859911006102

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
1-877-246-9283info@biowave.com

Regulatory Flags#

DUNS number
005759084
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859911006140BioWave Noninvasive ElectrodesGOPADS_12023-08-07
00859911006232BioWave Silver Back BioWrap S/MBWRPSILVER-BACK-SM2023-08-07
00859911006249BioWave Silver Knee BioWrap S/MBWRPSILVER-KNEE-SM2023-08-07
00859911006256BioWave Silver Foot-Ankle BioWrap S/MBWRPSILVER-FOOT-ANKLE-SM2023-08-07
00859911006461BioWave Silver Back BioWrap L/XLBWRPSILVER-BACK-LXL2023-08-07
00859911006492BioWave Silver Foot-Ankle BioWrap L/XLBWRPSILVER-FOOT-ANKLE-LXL2023-08-07
00859911006508BioWave Silver Knee BioWrap L/XLBWRPSILVER-KNEE-LXL2023-08-07
00859911006546BioWave Silver Thigh-Calf BioWrap S/MBWRPSILVER-THIGH-CALF-SM2023-08-07
00859911006560BioWave Silver Thigh-Calf BioWrap L/XLBWRPSILVER-THIGH-CALF-LXL2023-08-07
00859911006577BioWave BLUE Back BioWrap L/XLBWRPBLUE-BACK-LXL2023-08-07
00859911006584BioWave BLUE Back BioWrap S/MBWRPBLUE-BACK-SM2023-08-07
00859911006591BioWave BLUE Knee BioWrap L/XLBWRPBLUE-KNEE-LXL2023-08-07
00859911006607BioWave Noninvasive Velcro Backed Electrodes - B-SetBIOWRAP-PADS2023-08-07
00859911006669BioWave BLUE Knee BioWrap S/MBWRPBLUE-KNEE-SM2023-08-07
00859911006065BiowavePROBWPD012016-08-01
00859911006430BioWaveGO RXBWG-RX2023-06-15
00859911006010BioWaveGOBWG-S2021-07-26
00859911006072BiowaveHOMEBWHD012016-08-01
00859911006089Biowave Noninvasive ElectrodesMK78560 - BWEN01-B2016-08-01
00859911006096Biowave Noninvasive ElectrodesMK78570 - BWEN02-E2016-08-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808116actiTENSSUBLIMEDGZJ2026-05-27
03770018808253actiTENS MiniSUBLIMEDGZJ2026-05-27
03770018808260actiTENS MiniSUBLIMEDGZJ2026-05-27
08032625824480GLOBUSDOMINO SRLLIH2026-02-23
00714905117649Fab StimDrive Devilbiss HealthcareLIH2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareLIH2026-02-06
00714905710024Fab StimDrive Devilbiss HealthcareGZJ2026-02-06
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.GZJ2025-09-11
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00661168000181Reliefband® Premier PlusRELIEFBAND TECHNOLOGIES LLCGZJ2025-02-24
14897076723536E-Stim IIITENS PLUS INDUSTRIAL COMPANYGZJ2024-12-10
08032625822868GLOBUSDOMINO SRLLIH2024-11-20
08032625822875GLOBUSDOMINO SRLLIH2024-11-20
08032625822882GLOBUSDOMINO SRLLIH2024-11-20
08032625822851GLOBUSDOMINO SRLLIH2024-10-17
08032625828037GLOBUSDOMINO SRLLIH2024-10-17
08032625829799GLOBUSDOMINO SRLLIH2024-10-17
08032625829805GLOBUSDOMINO SRLLIH2024-10-17
08032625829812GLOBUSDOMINO SRLLIH2024-10-17
08032625822837GLOBUSDOMINO SRLLIH2024-09-04
08032625822844GLOBUSDOMINO SRLLIH2024-09-04
08032625825265GLOBUSDOMINO SRLLIH2024-09-04
08032625828020GLOBUSDOMINO SRLLIH2024-09-04