Electro-Mesh Glove

GUDID B872EMG20150

PRIZM MEDICAL, INC.

Transcutaneous electrical stimulation electrode

• Primary Device ID: B872EMG20150
• NIH Device Record Key: 4d1d075a-4fb7-413f-93c5-18ed033cfde0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Electro-Mesh Glove
• Version Model Number: EMG2015
• Company DUNS: 790271118
• Company Name: PRIZM 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B872EMG20150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K944487

FDA Product Code

• GXY: Electrode, Cutaneous

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: 2020-05-19
• Device Publish Date: 2020-05-11

On-Brand Devices [Electro-Mesh Glove]

• B872EMG20150: EMG2015
• B872EMG20140: EMG2014
• B872EMG20130: Electro-Mesh Glove - Medium