NeMa-st - soleve 08-810-00000

GUDID 07290019787013

The NeMa-st - Soleve device is intended for Transcutaneous Electrical nerve Stimulation for back pain relief. NeMa-st - Soleve is indicated for the relief and management of symptomatic chronic or intractable back pain and/or post-surgical back pain and/or post trauma back pain. Soleve is designed to deliver electrical stimulation using small contact surface probes. It includes an array of 26 probes connected to a motion system, enabling the provision of electrical stimulation to multiple points in the back.

LIGHTRAY-PLUS LTD

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 07290019787013
• NIH Device Record Key: b28f5806-18f1-4adc-8770-9ccdbe67c1e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeMa-st - soleve
• Version Model Number: 3.3
• Catalog Number: 08-810-00000
• Company DUNS: 521166280
• Company Name: LIGHTRAY-PLUS LTD
• Device Count: 1
• DM Exempt: true
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290019787013 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100668

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

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: 2023-11-28
• Device Publish Date: 2023-11-20

On-Brand Devices [NeMa-st - soleve]

• 07290019787006: The NeMa-st - Soleve device is intended for Transcutaneous Electrical nerve Stimulation for back
• 07290019787013: The NeMa-st - Soleve device is intended for Transcutaneous Electrical nerve Stimulation for back