ALLIVE
GUDID 08800051500021
Nu Eyne Co., Ltd.
Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator Craniofacial analgesia electrical stimulator| Primary Device ID | 08800051500021 |
| NIH Device Record Key | f434bb7b-f386-4c05-9d4c-0f46c9fcce68 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ALLIVE |
| Version Model Number | ALLIVE01 |
| Company DUNS | 695649163 |
| Company Name | Nu Eyne Co., Ltd. |
| 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 | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com | |
| Phone | +821071220306 |
| dongseong.lee@nueyne.com |
Operating and Storage Conditions
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Atmospheric Pressure | Between 50 KiloPascal and 106 KiloPascal |
| Storage Environment Humidity | Between 25 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between -5 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08800051500021 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K192773
FDA Product Code
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine |
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 | 2021-03-30 |
| Device Publish Date | 2021-03-22 |
Devices Manufactured by Nu Eyne Co., Ltd.
| 08800051500199 - ELEXIR | 2023-08-14 |
| 08800051500021 - ALLIVE | 2021-03-30 |
| 08800051500021 - ALLIVE | 2021-03-30 |
Trademark Results [ALLIVE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ALLIVE 90499728 not registered Live/Pending |
Wentian Precision Technology Co., Ltd. 2021-01-30 |
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