FDA.reportPublic FDA data

InterX

Primary DI
00851894007343
Brand
InterX
Company
HTK ENTERPRISES, INC.
Model
1589
Catalog number
1589-001
Device description
The InterX Electrode Accessories are a critical part of the InterX non-invasive interactive neurostimulation (NIN) system. The InterX Personal Flexible Array can be connected to both the InterX 1000 and InterX 5002 Devices via this Y-Cable. The InterX Personal Flexible Array is intended for single patient use. Both the InterX 1000 and InterX 5002 devices are designed to provide 10 minutes of treatment options and can be used unattended once treatment parameters have been set on either the InterX 1000 or InterX 5002 device or dynamically for muscle re-education. This Y-Cable along with the InterX Personal Flexible Array is indicated for symptomatic relief and management of chronic intractable pain and also adjunctive treatment in the management of post-surgical and post traumatic pain.
Published
2020-06-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851894007343PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851894007343008518940073438518940073430851894007343

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length98.7Centimeter
Weight58Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature15 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056903080
Device count
1
Premarket exempt
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851894007411InterXInterX XPad1750-0012026-04-21
00851894007428InterXXPad Y-Cable1761-0012026-04-21
00851894007367InterX16751675-0012025-05-09
00851894007114InterX3001070-0012020-06-01
00851894007138InterX5001155-0012020-06-01
00851894007145InterX5331220-0012020-06-01
00851894007169InterX150U1569-0012020-06-01
00851894007176InterX350U1674-0012020-06-01
00851894007183InterX4001072-0012020-06-01
00851894007213InterX2501538-0012020-06-01
00851894007244InterX15071507-0012020-06-01
00851894007251InterX14751475-0012020-06-01
00851894007336InterX2001075-0012020-06-01
00851894007008InterXProfessional Sport1140-0012016-09-24
00851894007015InterX50021141-0012016-09-24
00851894007022InterX10001149-0012016-09-24
00851894007039InterXPersonal Sport1150-0012016-09-24
00851894007046InterX9001478-0012016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08720791372323CadwellTechnomed Engineering B.V.GXY2024-05-02