BiowaveHOME
GUDID 00859911006072
BiowaveHOME Neurostimulator
BIOWAVE CORPORATION
Physical therapy transcutaneous neuromuscular electrical stimulation system| Primary Device ID | 00859911006072 |
| NIH Device Record Key | 02beb21f-04dc-4228-ba7f-a1ea8ca93b94 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BiowaveHOME |
| Version Model Number | BWHD01 |
| 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 |
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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859911006072 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152437
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 | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-10-23 |
| 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 [BiowaveHOME]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BIOWAVEHOME 85664963 4932692 Live/Registered |
Biowave Corporation 2012-06-29 |
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