StimOn

GUDID 04719873360093

StimOn™ Pain Relief System (GM2439) is a handheld stimulator designed to pass electrical signals via surface electrodes through the skin to the underlying nerves. It may be used as a TENS device to aid the blocking of pain signalstraveling to the brain.

GiMer Medical Company Limited

Analgesic transcutaneous electrical nerve stimulation system

• Primary Device ID: 04719873360093
• NIH Device Record Key: 43c9fd10-e85c-43e7-9483-911f3f7680af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: StimOn
• Version Model Number: GM2439
• Company DUNS: 656089214
• Company Name: GiMer Medical Company Limited
• 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: true
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com
• Phone: +886226972680
• Email: stimon.service@gimermed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04719873360093 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213802

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: 2023-08-04
• Device Publish Date: 2023-07-27