FDA.reportPublic FDA data

MediMax Tech

Primary DI
30817325020634
Brand
MediMax Tech
Company
MEDIMAX TECH INC.
Model
ST90RT Tens Electrode
Device description
ST90RT Tens Electrode - Premium 50x90mm Rectangle Stimulating Electrodes
Published
2016-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
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
10817325020630PackageGS110In Commercial Distribution
20817325020637PackageGS110In Commercial Distribution
30817325020634PackageGS15In Commercial Distribution
00817325020633PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081732502063010817325020630
2081732502063720817325020637
3081732502063430817325020634
00817325020633008173250206338173250206330817325020633

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile 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, 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-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
855-633-4629Malorie.c@medimaxtech.com

Regulatory Flags#

DUNS number
927071162
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817325023808MediMax TechTS32020-11-16
10817325023815MediMax TechTV32020-11-16
10817325023822MediMax TechTO3 2020-11-16
10817325026571MediMaxTech Inc.MSH22M2024-03-25
10817325023792MediMax TechASFT032020-09-24
10817325023761MediMax TechPSF22020-09-24
10817325023778MediMax TechASF32020-09-24
10817325023785MediMax TechASFN32020-09-24
20817325023638MediMax TechSPDE-SL52019-12-02
20817325023652MediMax TechSPDEI-SL52019-12-02
20817325023683MediMax TechSPEC-SL52019-12-02
20817325023706MediMax TechSPECI-SL52019-12-02
20817325023720MediMax TechSPST-SL52019-12-02
20817325023744MediMax TechSPSTI-SL52019-12-02
20817325023621MediMax TechSPDE-SL2019-12-02
20817325023645MediMax TechSPDEI-SL2019-12-02
20817325023669MediMax TechSPEC-SL2019-12-02
20817325023690MediMax TechSPECI-SL2019-12-02
20817325023713MediMax TechSPST-SL2019-12-02
20817325023737MediMax TechSPSTI-SL2019-12-02

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Primary DI, Brand, Company table
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