ReBuilder Medical

GUDID B1870611

Conductive mitt, 2/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: B1870611
• NIH Device Record Key: 56a1a005-913b-49e8-b356-228fa8d218cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ReBuilder Medical
• Version Model Number: PLB033-5070W
• Company DUNS: 147018519
• Company Name: NEUROTRON MEDICAL, INC.
• Device Count: 2
• 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	B1870610 [Unit of Use]
HIBCC	B1870611 [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: 2017-06-09

On-Brand Devices [ReBuilder Medical]

• B1870611: Conductive mitt, 2/package
• B1870511: Conductive pad, 2 in. x 50 in., 2/package
• B1870501: Conductive pad, 2 in. x 18 in., 2/package
• B1870331: Conductive foot pad, 4 in. x 13 in., 2/package
• B1870321: Conductive sock (ankle), single polarity, 2/package
• B1870311: Conductive glove, single polarity, 2/package
• B1870271: Conductive pad, 2 in. x 32 in., 2/package
• B1870261: Conductive pad, 2 in. x 24 in., 2/package