PDC Restorer

GUDID B1870490

Conductive duo-glove, dual polarity, 1/package

NEUROTRON MEDICAL, INC.

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: B1870490
• NIH Device Record Key: a5b5cf88-1412-4b9a-970a-1788ebf4a321
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PDC Restorer
• Version Model Number: PLB066-3026C
• Company DUNS: 147018519
• Company Name: NEUROTRON 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: false
• 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
HIBCC	B1870490 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K053214

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-01-15

On-Brand Devices [PDC Restorer]

• B1870620: Electrolyte solution, 4 oz. spray bottle
• B1870490: Conductive duo-glove, dual polarity, 1/package
• B1870480: Conductive duo-sock, dual polarity, 1/package
• B1870460: Conductive sock (std.), single polarity, 1/package
• B1870450: Conductive glove, single polarity, 1/package
• B1870740: Conductive duo-elbow, dual polarity, 1/package
• B1870760: Conductive duo-sock, dual polarity, X-Large, 1/package
• B1870770: Conductive duo-knee, dual polarity, 1/package
• B1870780: Conductive pad, 3 in. x 5 in., 2/package