| Primary Device ID | 00851329005463 |
| NIH Device Record Key | 5fcca966-12f6-4a15-a8ce-def3d1655ab6 |
| Commercial Distribution Discontinuation | 2031-03-03 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | KT RECOVERY+ WAVE |
| Version Model Number | 088 |
| Catalog Number | 100-KT |
| Company DUNS | 101591571 |
| Company Name | Bioelectronics 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 | true |
| 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 | false |
| OTC Over-The-Counter | true |
| Phone | 3018744890 |
| skoneru@bielcorp.com | |
| Phone | 3018744890 |
| skoneru@bielcorp.com | |
| Phone | 3018744890 |
| skoneru@bielcorp.com | |
| Phone | 3018744890 |
| skoneru@bielcorp.com | |
| Phone | 3018744890 |
| skoneru@bielcorp.com | |
| Phone | 3018744890 |
| skoneru@bielcorp.com | |
| Phone | 3018744890 |
| skoneru@bielcorp.com | |
| Phone | 3018744890 |
| skoneru@bielcorp.com | |
| Phone | 3018744890 |
| skoneru@bielcorp.com | |
| Phone | 3018744890 |
| skoneru@bielcorp.com | |
| Phone | 3018744890 |
| skoneru@bielcorp.com | |
| Phone | 3018744890 |
| skoneru@bielcorp.com | |
| Phone | 3018744890 |
| skoneru@bielcorp.com |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -13 Degrees Fahrenheit and 158 Degrees Fahrenheit |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851329005463 [Primary] |
| PQY | Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-11 |
| Device Publish Date | 2021-03-03 |
| 00851329005241 - ActiPatch | 2021-06-17 ActiPatch Knee Pain Therapy Device 5 pack |
| 00851329005258 - ActiPatch | 2021-06-17 ActiPatch Muscle and Joint Pain Therapy Kit 5 pack |
| 00851329005470 - ActiPatch | 2021-06-17 ActiPatch Back Pain Relief Therapy 100 pack |
| 00851329005487 - ActiPatch | 2021-06-17 ActiPatch Knee Pain Relief Therapy 100 pack |
| 00851329005494 - ActiPatch | 2021-06-17 ActiPatch Muscle and Joint Relief Therapy 100 pack |
| 80851329005155 - ActiPatch | 2021-06-17 ActiPatch Back Pain Therapy Kit 5 pack |
| 00851329005128 - RecoveryRx | 2021-03-11 RecoveryRx Postoperative Pain Therapy Kit 720 hours |
| 00851329005463 - KT RECOVERY+ WAVE | 2021-03-11KT RECOVERY+ WAVE Electromagnetic Pain Relief |
| 00851329005463 - KT RECOVERY+ WAVE | 2021-03-11 KT RECOVERY+ WAVE Electromagnetic Pain Relief |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() KT RECOVERY+ WAVE 90376306 not registered Live/Pending |
KT Health, LLC 2020-12-11 |