TruWave TENS

GUDID 00852670007021

An electrotherapy device which provides symptomatic pain relief with Transcutaneous Electrical Nerve Stimulation

ZYNEX MEDICAL, INC.

Analgesic transcutaneous electrical nerve stimulation system
Primary Device ID00852670007021
NIH Device Record Keyc54db598-88f7-4a20-80f4-83edd19a2afb
Commercial Distribution StatusIn Commercial Distribution
Brand NameTruWave TENS
Version Model Number400420
Company DUNS141582226
Company NameZYNEX MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com
Phone800-495-6670
Emailcustomersupport@zynex.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100852670007021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-05
Device Publish Date2021-01-28

Devices Manufactured by ZYNEX MEDICAL, INC.

00852670007540 - M-Wave2024-03-26 An electrotherapy, muscle stimulator device.
00852670007045 - E-Wave2023-06-15 An electrotherapy, muscle stimulator device.
00852670007007 - NexWave2021-02-05 An electrotherapy device which offers the user a choice of three operational modes: IFC, TENS, and NMES.
00852670007021 - TruWave TENS2021-02-05An electrotherapy device which provides symptomatic pain relief with Transcutaneous Electrical Nerve Stimulation
00852670007021 - TruWave TENS2021-02-05 An electrotherapy device which provides symptomatic pain relief with Transcutaneous Electrical Nerve Stimulation
00852670007038 - NeuroMove2021-02-05 EMG-triggered NeuroMuscular stimulator to aid in stroke recovery
00852670007052 - InWave2021-02-05 Electrotherapy device for treatment of urinary incontinence.
00852670007151 - CM-1500 Wrist Cuff2021-02-05 Wrist Wearable for the use with the CM-1500 cardiac monitoring unit.
00852670007076 - Zynex Medical Electrodes2018-11-01 Electrode 2” Round , 4 per Package

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