BiowavePRO
GUDID 00859911006065
BiowavePRO Neurostimulator
BIOWAVE CORPORATION
Analgesic percutaneous electrical nerve stimulation system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system Analgesic PENS system| Primary Device ID | 00859911006065 |
| NIH Device Record Key | 2a4c34b5-7643-4bf2-9c60-fc67ae204dfc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BiowavePRO |
| Version Model Number | BWPD01 |
| 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 | true |
| Manufacturing Date | true |
| 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 |
Customer Support Contacts
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com | |
| Phone | 1-877-246-9283 |
| info@biowave.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 40 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859911006065 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K061166
FDA Product Code
| NHI | Stimulator, Nerve, Electrial, Percutaneous (Pens), For Pain Relief |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-23 |
| Device Publish Date | 2016-08-01 |
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 | 2023-08-15 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 |
Trademark Results [BiowavePRO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOWAVEPRO 85664952 4297794 Live/Registered |
Biowave Corporation 2012-06-29 |
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