FDA.reportPublic FDA data

Electro-Mesh Panel

Primary DI
B872EMSP240
Brand
Electro-Mesh Panel
Company
PRIZM MEDICAL, INC.
Model
EMSP24
Device description
Electro-Mesh Panel 1.5x4
Published
2024-06-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
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
K944487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K944487000ELECTRO-MESH SOCK, WRAP, AND SLEEVE ELECTRODESPrizm Medical, Inc.1995-02-21GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B872EMSP240PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
790271118
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B872MZ2KIT20Micro-Z IIMZ2KIT22020-05-12
B872MZM1000Micro-Z Mini MZM1002020-05-07
B872MZS2KIT20Micro-Z IIMZ2KIT22020-05-07
B872ITBK440Intelligent Textile Stim-Support Back WrapITBK442024-06-07
B872SSELBW0Stim-Support Elbow BraceSSELBW2024-06-07
B872SSKNEE0Stim-Support Knee BraceSSKNEE2024-06-07
B872SSNECK0Stim-Support Neck BraceSSNECK2024-06-07
B872SSSHLD0Stim-Support Shoulder BraceSSSHLD2024-06-07
B872EMG20130Electro-Mesh GloveEMG20132024-06-06
B872EMSP440Electro-Mesh PanelEMSP442024-06-06
B872EMSP480Electro-Mesh PanelEMSP482024-06-06
B872STS33130Silver-Thera SockSTS33132024-06-06
B872STS33140Silver-Thera SockSTS33142024-06-06
B872STS33150Silver-Thera SockSTS33152024-06-06
B872SSS23050Stim-Support Shoulder - XLSSS 23052020-05-11
B872SPZ2000Sport-ZSPZ2002020-05-11
B872REVSTM20ReviStimREVSTM22020-05-07
D20007Micro-Z IIMZ2KIT22020-05-12
B872EMG20140Electro-Mesh GloveEMG20142020-05-11
B872EMG20150Electro-Mesh GloveEMG20152020-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
00850055335004iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335011iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335028iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
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