VEINOPLUS
GUDID 03701084900015
AD REM TECHNOLOGY
Physical therapy transcutaneous neuromuscular electrical stimulation system| Primary Device ID | 03701084900015 |
| NIH Device Record Key | 4100cdc5-9d65-4b60-af30-a0d0eba0c9d6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VEINOPLUS |
| Version Model Number | 2.1 |
| Company DUNS | 273234679 |
| Company Name | AD REM TECHNOLOGY |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Unsafe |
| 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 | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com | |
| Phone | +33(0)142600022 |
| info@veinoplus.com |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Storage Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
| Handling Environment Temperature | Between 41 Degrees Fahrenheit and 80.6 Degrees Fahrenheit |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 50 Percent (%) Relative Humidity |
| Handling Environment Atmospheric Pressure | Between 85 KiloPascal and 106 KiloPascal |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03701084900015 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K072252
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 | 2016-09-19 |
Devices Manufactured by AD REM TECHNOLOGY
| 03701084900008 - VEINOPLUS PACK | 2021-02-19 |
| 03701084900015 - VEINOPLUS | 2019-10-23 |
| 03701084900015 - VEINOPLUS | 2019-10-23 |
| 03701084900022 - VEINOPLUS DVT | 2019-10-23 |
| 03701084900039 - VEINOPLUS SPORT | 2019-10-23 |
Trademark Results [VEINOPLUS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VEINOPLUS 79016052 3159115 Live/Registered |
VEINOPLUS HONG KONG LIMITED 2005-04-25 |
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