LE BioSleeve 71

GUDID B3677110

Cutaneous Electrode Garment

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: B3677110
• NIH Device Record Key: 442e7c9f-4230-4218-8a47-48f49f4b8702
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: LE BioSleeve
• Version Model Number: 1
• Catalog Number: 71
• 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: false
• Serial Number: true
• 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	B3677110 [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 [LE BioSleeve]

• B3677110: Cutaneous Electrode Garment
• B3677010: Cutaneous Electrode Garment
• B3676980: Cutaneous Electrode Garment
• B3676970: Cutaneous Electrode Garment
• B3676800: Cutaneous Electrode Garment
• B3676700: Cutaneous Electrode Garment
• B3676600: Cutaneous Electrode Garment
• B3676500: Cutaneous Electrode Garment
• B3676400: Cutaneous Electrode Garment