Tuttle Rehab

GUDID B1870522

TENS gel electrode, 2in. x 2in., 4/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: B1870522
• NIH Device Record Key: 0deb0332-44d2-4d56-b687-d8def76d6996
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tuttle Rehab
• Version Model Number: PLB051-2020C
• Company DUNS: 147018519
• Company Name: NEUROTRON MEDICAL, INC.
• Device Count: 4
• 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: true
• 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	B1870520 [Unit of Use]
HIBCC	B1870522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K081279

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: 2016-10-26

On-Brand Devices [Tuttle Rehab]

• B1870532: TENS gel electrode, 2in. x 4in., 4/package
• B1870522: TENS gel electrode, 2in. x 2in., 4/package