BioWave BLUE Back BioWrap L/XL

GUDID 00859911006577

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

• Primary Device ID: 00859911006577
• NIH Device Record Key: d9cf79a8-1330-41d2-87c8-4ede8b50602a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioWave BLUE Back BioWrap L/XL
• Version Model Number: BWRPBLUE-BACK-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	00859911006577 [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

Devices Manufactured by BIOWAVE CORPORATION

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• 00859911006508 - BioWave Silver Knee BioWrap L/XL: 2023-08-15 BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively w
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