NexWave
GUDID 00852670007007
An electrotherapy device which offers the user a choice of three operational modes: IFC, TENS, and NMES.
ZYNEX MEDICAL, INC.
Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system Physical therapy transcutaneous neuromuscular electrical stimulation system| Primary Device ID | 00852670007007 |
| NIH Device Record Key | 01e089b2-2356-4639-8db4-d6ac394f8c87 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NexWave |
| Version Model Number | 400400 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00852670007007 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K111279
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 | 2021-02-05 |
| Device Publish Date | 2021-01-28 |
Devices Manufactured by ZYNEX MEDICAL, INC.
| 00852670007540 - M-Wave | 2024-03-26 An electrotherapy, muscle stimulator device. |
| 00852670007045 - E-Wave | 2023-06-15 An electrotherapy, muscle stimulator device. |
| 00852670007007 - NexWave | 2021-02-05An electrotherapy device which offers the user a choice of three operational modes: IFC, TENS, and NMES. |
| 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 [NexWave]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEXWAVE 98014864 not registered Live/Pending |
Shenzhen Leyue Lerui Technology Co., Ltd. 2023-05-26 |
 NEXWAVE 90897066 not registered Live/Pending |
RSP Industries Inc. 2021-08-23 |
 NEXWAVE 88237982 not registered Live/Pending |
Lei Huaiyuan 2018-12-20 |
 NEXWAVE 87112473 5454231 Live/Registered |
NEXWAVE CAPITAL PARTNERS LLC 2016-07-21 |
 NEXWAVE 86283137 4697305 Live/Registered |
General Communications, Inc. 2014-05-16 |
 NEXWAVE 85557418 not registered Dead/Abandoned |
Zynex Medical, Inc. 2012-03-01 |
 NEXWAVE 77746453 not registered Dead/Abandoned |
NexAira, Inc. 2009-05-28 |
 NEXWAVE 76191991 not registered Dead/Abandoned |
Suntech SA 2001-01-03 |
 NEXWAVE 76188046 not registered Dead/Abandoned |
Suntech SA 2000-12-29 |
 NEXWAVE 76184869 2927112 Dead/Cancelled |
NEXWAVE SOLUTIONS, SOCIETE ANONYME 2000-12-20 |
 NEXWAVE 76184411 3280262 Dead/Cancelled |
NEXWAVE SOLUTIONS, SOCIETE ANONYME 2000-12-20 |
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