BioGel Velcro Electrode 116P

GUDID B367116P20

Cutaneous Electrode Pair 1.5” x 1.5”

AXIOBIONICS

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: B367116P20
• NIH Device Record Key: 0d2ce4d1-ba26-4959-9344-d3523e687e7b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioGel Velcro Electrode
• Version Model Number: 2
• Catalog Number: 116P
• Company DUNS: 033139835
• Company Name: AXIOBIONICS
• 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	B367116P20 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141342

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: 2016-09-24

On-Brand Devices [BioGel Velcro Electrode]

• B367136P20: Cutaneous Electrode Pair 4" x 6"
• B367135P20: Cutaneous Electrode Pair 4" x 4"
• B367134P20: Cutaneous Electrode Pair 3.5" x 3.5"
• B367133P20: Cutaneous Electrode Pair 3” x 5”
• B367130P20: Cutaneous Electrode Pair 1" x 1.5"
• B367128P20: Cutaneous Electrode Pair 1.5" x 6"
• B367127P20: Cutaneous Electrode Pair 1.5" x 5"
• B367126P20: Cutaneous Electrode Pair 1.5" x 3"
• B367125P20: Cutaneous Electrode Pair 2” x 8”
• B367124P20: Cutaneous Electrode Pair 2” x 6”
• B367123P20: Cutaneous Electrode Pair 2" x 5"
• B367122P20: Cutaneous Electrode Pair 2" x 4"
• B367121P20: Cutaneous Electrode Pair 2" x 3.5"
• B367120P20: Cutaneous Electrode Pair 2” x 3”
• B367119P20: Cutaneous Electrode Pair 2" x 2.5"
• B367118P20: Cutaneous Electrode Pair 2” x 2”
• B367117P20: Cutaneous Electrode Pair 1.5” x 2”
• B367116P20: Cutaneous Electrode Pair 1.5” x 1.5”
• B367115P20: Cutaneous Electrode Pair 1.25” x 1.25”