FDA.reportPublic FDA data

BioWave Silver Knee BioWrap S/M

Primary DI
00859911006249
Brand
BioWave Silver Knee BioWrap S/M
Company
BIOWAVE CORPORATION
Model
BWRPSILVER-KNEE-SM
Device description
BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric 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
Rx
true
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
00859911006249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859911006249008599110062498599110062490859911006249

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
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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00382830063869NatusXLTEKGXY2026-10-15
00382830063876NatusXLTEKGXY2026-10-15
00382830063883NatusXLTEKGXY2026-10-15
00382830063890NatusXLTEKGXY2026-10-15
00382830063906NatusXLTEKGXY2026-10-15
00382830063913NatusXLTEKGXY2026-10-15
00382830063920NatusXLTEKGXY2026-10-15
00382830063937NatusXLTEKGXY2026-10-15
06973602731105Premium Gel White Fabri ElectrodesTOP-RANK HEALTH CARE CO., LTD.GXY2026-10-12
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00860014334320PASCALL SYSTEMS, INC.PASCALL SYSTEMS, INC.GXY2026-09-04
08720791379131EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379148EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379155EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379162EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379179EZ1020Technomed Engineering B.V.GXY2026-08-07
08720791379209EZ1020Technomed Engineering B.V.GXY2026-08-07
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