TheraKnit

GUDID B1870670

Conductive pad kit: 2 pc. 3 in. x 4.5 in.; 1 pc. 3 in. x 7 in.; 1 pc. 1.5 in. x 7 in.

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: B1870670
• NIH Device Record Key: 8422ef55-9510-4c10-96a9-1aaab4046976
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TheraKnit
• Version Model Number: TKK-001
• 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: true
• 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	B1870670 [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: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-27

On-Brand Devices [TheraKnit]

• B1870670: Conductive pad kit: 2 pc. 3 in. x 4.5 in.; 1 pc. 3 in. x 7 in.; 1 pc. 1.5 in. x 7 in.
• B1870141: Conductive pad, 1.5 in. x 8 in., 2/package
• B1870121: Conductive pad, 3 in. x 5 in., 2/package
• B1870111: Conductive pad, 2 in. x 3 in., 2/package
• B1870090: Conductive duo-glove, dual polarity, 1/package
• B1870070: Conductive duo-elbow, dual polarity, 1/package
• B1870060: Conductive sock, dual polarity, 1/package
• B1870050: Conductive knee, single polarity, 1/package
• B1870020: Conductive sock, single polarity, 1/package
• B1870010: Conductive glove, single polarity, 1/package
• B1870080: Conductive duo-knee, dual polarity, 1/package