E-Wave

GUDID 00852670007045

An electrotherapy, muscle stimulator device.

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

• 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
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: customersupport@zynex.com
• Phone: 800-495-6670
• Email: 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