FDA.reportPublic FDA data

InterX

Primary DI
00851894007244
Brand
InterX
Company
HTK ENTERPRISES, INC.
Model
1507
Catalog number
1507-001
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 the InterX 900 Device via this Y-Cable. It is designed to provide 20 minutes of treatment options and can be used unattended once treatment parameters have been set on the InterX 900 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

Contact Domains#

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
00851894007244PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851894007244008518940072448518940072440851894007244

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

Contacts#

Phone, Email table
PhoneEmail
972-665-1810info@interx.com
469-364-3420info@interxtherapycenter.com

Regulatory Flags#

DUNS number
056903080
Device count
1
Premarket exempt
true
Serial number
true
Expiration date on label
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
00851894007251InterX14751475-0012020-06-01
00851894007336InterX2001075-0012020-06-01
00851894007343InterX15891589-0012020-06-01
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