FDA.reportPublic FDA data

BioWave BLUE Knee BioWrap L/XL

Primary DI
00859911006591
Brand
BioWave BLUE Knee BioWrap L/XL
Company
BIOWAVE CORPORATION
Model
BWRPBLUE-KNEE-LXL
Device description
BioWrap Wearable Compression Electrode Garment that utilizes BioWave Velcro-backed noninvasive electrodes that work exclusively with BioWave 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
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203158000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203158000BioWave BioWrapsBiowave Corporation2021-07-08GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859911006591PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859911006591008599110065918599110065910859911006591

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
1

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372163CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372187CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372200CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372224CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372248CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372262CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372286CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372309CadwellTechnomed Engineering B.V.GXY2024-05-02