FDA.reportPublic FDA data

BioWave Noninvasive Electrodes

Primary DI
00859911006140
Brand
BioWave Noninvasive Electrodes
Company
BIOWAVE CORPORATION
Model
GOPADS_1
Device description
BioWave Noninvasive Electrodes - 3 pack (3 pairs) - for use with BioWaveGO High Frequency Neurostimulators
Published
2023-08-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180943000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180943000BioWaveGOBiowave Corporation2018-08-17GZJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859911006140PrimaryGS10
00859911006683Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859911006140008599110061408599110061400859911006140
00859911006683008599110066838599110066830859911006683

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, reusableAn 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 reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005759084
Device count
3

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00859911006102Biowave Noninvasive ElectrodesMK78580 - BWEN03-U2016-08-01

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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