BioWave Silver Back BioWrap S/M

GUDID 00859911006232

BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively with BioWave High Frequency Neurostimulators.

BIOWAVE CORPORATION

Transcutaneous electrical stimulation electrode, reusable

• Primary Device ID: 00859911006232
• NIH Device Record Key: f4124836-3275-4925-b22d-3362d4072d92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioWave Silver Back BioWrap S/M
• Version Model Number: BWRPSILVER-BACK-SM
• 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: true
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859911006232 [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

• 00859911006140 - BioWave Noninvasive Electrodes: 2023-08-15 BioWave Noninvasive Electrodes - 3 pack (3 pairs) - for use with BioWaveGO High Frequency Neurostimulators
• 00859911006232 - BioWave Silver Back BioWrap S/M: 2023-08-15BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively with BioWave High Frequency Neurostimulators.
• 00859911006232 - BioWave Silver Back BioWrap S/M: 2023-08-15 BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively w
• 00859911006249 - BioWave Silver Knee BioWrap S/M: 2023-08-15 BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively w
• 00859911006256 - BioWave Silver Foot-Ankle BioWrap S/M: 2023-08-15 BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively w
• 00859911006461 - BioWave Silver Back BioWrap L/XL: 2023-08-15 BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively w
• 00859911006492 - BioWave Silver Foot-Ankle BioWrap L/XL: 2023-08-15 BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively w
• 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
• 00859911006546 - BioWave Silver Thigh-Calf BioWrap S/M: 2023-08-15 BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively w