CM-1500 Wrist Cuff

GUDID 00852670007151

Wrist Wearable for the use with the CM-1500 cardiac monitoring unit.

ZYNEX MEDICAL, INC.

Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable Wearable multiple physiological parameter recorder, reusable

• Primary Device ID: 00852670007151
• NIH Device Record Key: 6955db89-95dd-47fb-9f5a-532509c2e949
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: CM-1500 Wrist Cuff
• Version Model Number: 700460
• 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: false
• 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
• 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	00852670007151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191697

FDA Product Code

• DQA: Oximeter

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: 2021-02-05 Electrotherapy device for treatment of urinary incontinence.
• 00852670007151 - CM-1500 Wrist Cuff: 2021-02-05Wrist Wearable for the use with the CM-1500 cardiac monitoring unit.
• 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