E-Wave
GUDID 00852670007045
An electrotherapy, muscle stimulator device.
ZYNEX MEDICAL, INC.
Physical therapy transcutaneous neuromuscular electrical stimulation system| Primary Device ID | 00852670007045 |
| NIH Device Record Key | f4515647-a8cf-47a7-a06a-253abb3f95e2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | E-Wave |
| Version Model Number | 700240 |
| Company DUNS | 141582226 |
| Company Name | ZYNEX MEDICAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com | |
| Phone | 800-495-6670 |
| customersupport@zynex.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852670007045 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K010745
FDA Product Code
| IPF | Stimulator, Muscle, Powered |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-15 |
| Device Publish Date | 2023-06-07 |
Devices Manufactured by ZYNEX MEDICAL, INC.
| 00852670007540 - M-Wave | 2024-03-26 An electrotherapy, muscle stimulator device. |
| 00852670007045 - E-Wave | 2023-06-15An electrotherapy, muscle stimulator device. |
| 00852670007045 - E-Wave | 2023-06-15 An electrotherapy, muscle stimulator device. |
| 00852670007007 - NexWave | 2021-02-05 An electrotherapy device which offers the user a choice of three operational modes: IFC, TENS, and NMES. |
| 00852670007021 - TruWave TENS | 2021-02-05 An electrotherapy device which provides symptomatic pain relief with Transcutaneous Electrical Nerve Stimulation |
| 00852670007038 - NeuroMove | 2021-02-05 EMG-triggered NeuroMuscular stimulator to aid in stroke recovery |
| 00852670007052 - InWave | 2021-02-05 Electrotherapy device for treatment of urinary incontinence. |
| 00852670007151 - CM-1500 Wrist Cuff | 2021-02-05 Wrist Wearable for the use with the CM-1500 cardiac monitoring unit. |
| 00852670007076 - Zynex Medical Electrodes | 2018-11-01 Electrode 2” Round , 4 per Package |
Trademark Results [E-Wave]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 E-WAVE 90906220 not registered Live/Pending |
American Flyer, LLC 2021-08-27 |
 E-WAVE 85232203 not registered Dead/Abandoned |
Skechers U.S.A., Inc. II 2011-02-02 |
 E-WAVE 75491739 2472646 Live/Registered |
Wilkinson, Chris 1998-05-27 |
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