| Primary Device ID | 00859911006492 |
| NIH Device Record Key | 3b4d7d59-fd4d-4b8b-bfda-77c01567028b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BioWave Silver Foot-Ankle BioWrap L/XL |
| Version Model Number | BWRPSILVER-FOOT-ANKLE-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 | true |
| OTC Over-The-Counter | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00859911006492 [Primary] |
| GXY | Electrode, Cutaneous |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-15 |
| Device Publish Date | 2023-08-07 |
| 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 | 2023-08-15BioWrap Wearable Compression Electrode Garment that utilizes advanced permanent silver fabric electrodes that work exclusively with BioWave High Frequency Neurostimulators. |
| 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 |