InWave

GUDID 00852670007052

Electrotherapy device for treatment of urinary incontinence.

ZYNEX MEDICAL, INC.

Transcutaneous incontinence-control electrical stimulator

• Primary Device ID: 00852670007052
• NIH Device Record Key: 5929cee1-547a-44ea-8c70-766a7df0408d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InWave
• Version Model Number: 400410
• 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: 8004956670
• Email: customersupport@zynex.com
• Phone: 8004956670
• Email: customersupport@zynex.com
• Phone: 8004956670
• Email: customersupport@zynex.com
• Phone: 8004956670
• Email: customersupport@zynex.com
• Phone: 8004956670
• Email: customersupport@zynex.com
• Phone: 8004956670
• Email: customersupport@zynex.com
• Phone: 8004956670
• Email: customersupport@zynex.com
• Phone: 8004956670
• Email: customersupport@zynex.com
• Phone: 8004956670
• Email: customersupport@zynex.com
• Phone: 8004956670
• Email: customersupport@zynex.com
• Phone: 8004956670
• Email: customersupport@zynex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852670007052 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121820

FDA Product Code

• KPI: Stimulator, Electrical, Non-Implantable, For Incontinence

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: 2021-02-05 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: 2021-02-05Electrotherapy device for treatment of urinary incontinence.
• 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