BioWave Noninvasive Electrodes

GUDID 00859911006140

BioWave Noninvasive Electrodes - 3 pack (3 pairs) - for use with BioWaveGO High Frequency Neurostimulators

BIOWAVE CORPORATION

Transcutaneous electrical stimulation electrode, reusable

• Primary Device ID: 00859911006140
• NIH Device Record Key: 580592f0-d3f9-4a46-916e-c3768334177d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioWave Noninvasive Electrodes
• Version Model Number: GOPADS_1
• Company DUNS: 005759084
• Company Name: BIOWAVE CORPORATION
• Device Count: 3
• 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	00859911006140 [Primary]
GS1	00859911006683 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180943

FDA Product Code

• GZJ: Stimulator, Nerve, Transcutaneous, For Pain Relief

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

On-Brand Devices [BioWave Noninvasive Electrodes]

• 20859911006106: Biowave Noninvasive Electrode - U-Set
• 20859911006090: Biowave Noninvasive Electrode - E-Set
• 20859911006083: Biowave Noninvasive Electrode - B-Set
• 00859911006140: BioWave Noninvasive Electrodes - 3 pack (3 pairs) - for use with BioWaveGO High Frequency Neuros