BioWave BLUE Knee BioWrap L/XL

GUDID 00859911006591

BioWrap Wearable Compression Electrode Garment that utilizes BioWave Velcro-backed noninvasive electrodes that work exclusively with BioWave High Frequency Neurostimulators.

BIOWAVE CORPORATION

Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable Transcutaneous electrical stimulation electrode, reusable

• Primary Device ID: 00859911006591
• NIH Device Record Key: 094771ef-78f0-47ae-bed5-27fc6259be42
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioWave BLUE Knee BioWrap L/XL
• Version Model Number: BWRPBLUE-KNEE-LXL
• Company DUNS: 005759084
• Company Name: BIOWAVE CORPORATION
• 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: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859911006591 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203158

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: 1
• Public Version Date: 2023-08-15
• Device Publish Date: 2023-08-07

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