ActiPatch 168
GUDID 00851329005203
Back , Knee, Muscle and Joint 7 day trial
Bioelectronics Corporation
Hand-held deep-tissue electromagnetic stimulator| Primary Device ID | 00851329005203 |
| NIH Device Record Key | 97401496-47f3-4e49-8843-1e3ab056c1ad |
| Commercial Distribution Discontinuation | 2025-07-23 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ActiPatch |
| Version Model Number | 077 |
| Catalog Number | 168 |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | true |
Customer Support Contacts
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com | |
| Phone | 301-874-4890 |
| skoneru@bielcorp.com |
Device Dimensions
| Outer Diameter | 15 Inch |
| Outer Diameter | 15 Inch |
| Outer Diameter | 15 Inch |
| Outer Diameter | 15 Inch |
| Outer Diameter | 15 Inch |
| Outer Diameter | 15 Inch |
| Outer Diameter | 15 Inch |
| Outer Diameter | 15 Inch |
| Outer Diameter | 15 Inch |
| Outer Diameter | 15 Inch |
| Outer Diameter | 15 Inch |
| Outer Diameter | 15 Inch |
| Outer Diameter | 15 Inch |
| Outer Diameter | 15 Inch |
Operating and Storage Conditions
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Humidity | Between 15 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851329005203 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K152432
FDA Product Code
| PQY | Nonthermal Shortwave Therapy Device Indicated For Over The Counter Use For The Treatment Of Pain |
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 | 2020-07-31 |
| Device Publish Date | 2020-07-23 |
On-Brand Devices [ActiPatch]
| 00851329005050 | Back Pain Advanced long -Lasting Relief |
| 00851329005340 | Back, Knee, Muscle & Joint Advanced Long-Lasting Relief. |
| 00851329005203 | Back , Knee, Muscle and Joint 7 day trial |
| 00851329005159 | Back Pain Advanced Long-Lasting Relief |
| 00851329005012 | Knee Pain Advanced Long-Lasting Relief |
| 80851329005155 | ActiPatch Back Pain Therapy Kit 5 pack |
| 00851329005494 | ActiPatch Muscle and Joint Relief Therapy 100 pack |
| 00851329005487 | ActiPatch Knee Pain Relief Therapy 100 pack |
| 00851329005470 | ActiPatch Back Pain Relief Therapy 100 pack |
| 00851329005258 | ActiPatch Muscle and Joint Pain Therapy Kit 5 pack |
| 00851329005241 | ActiPatch Knee Pain Therapy Device 5 pack |
Trademark Results [ActiPatch]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACTIPATCH 77922562 3899022 Live/Registered |
BioElectronics Corporation 2010-01-28 |
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