PURELIFT PURELIFT PRO PLUS
GUDID 00860008851031
The PureLift Pro Plus device is a handheld device intended to apply electrical impulses to strategic locations on the face. The device probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10). These device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D).The outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device is powered by a 3.7-volt battery which produces a low-level current that is transmitted through two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face with the use of conductive gel. The PureLift Pro Plus unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.
Xtreem Pulse LLC
Facial muscle cosmesis electrical stimulator| Primary Device ID | 00860008851031 |
| NIH Device Record Key | aa73e3e5-7077-496a-9747-857604488096 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PURELIFT |
| Version Model Number | PRO PLUS |
| Catalog Number | PURELIFT PRO PLUS |
| Company DUNS | 079809275 |
| Company Name | Xtreem Pulse LLC |
| 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 | false |
| Manufacturing Date | false |
| 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 |
Device Dimensions
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
| Height | 20.7 Centimeter |
| Width | 4.8 Centimeter |
| Outer Diameter | 4.5 Centimeter |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Atmospheric Pressure | Between 700 KiloPascal and 1060 KiloPascal |
| Handling Environment Humidity | Between 10 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity |
| Storage Environment Temperature | Between 10 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860008851031 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K221443
FDA Product Code
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
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 | 2023-10-09 |
| Device Publish Date | 2023-09-30 |
On-Brand Devices [PURELIFT]
| 00860008851048 | The PureLift Pro Edition device is a handheld device intended to apply electrical impulses to st |
| 00860008851031 | The PureLift Pro Plus device is a handheld device intended to apply electrical impulses to strat |
| 00860008851024 | The PureLift Face device is a hand-held device intended to apply electrical impulses to strategi |
| 00860008851017 | The PureLift Pro device is a handheld device intended to apply electrical impulses to strategic |
Trademark Results [PURELIFT]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PURELIFT 87729700 5553705 Live/Registered |
Xtreem Pulse LLC 2017-12-21 |
 PURELIFT 79241382 5864709 Live/Registered |
Hettich Marketing- und Vertriebs GmbH &Co. KG 2018-06-25 |
 PURELIFT 76718057 not registered Dead/Abandoned |
GARDEN SPRINGS., LL.C. 2015-05-26 |
 PURELIFT 76517991 2865588 Dead/Cancelled |
AUSTRALIAN GOLD, INC. 2003-05-29 |
 PURELIFT 76221376 not registered Dead/Abandoned |
Mellon, Micheal G. 2001-03-07 |
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