AccessGUDID - DEVICE: PURELIFT (00860008851031)

GUDID

Device Identifier (DI) Information

Brand Name: PURELIFT
Version or Model: PRO PLUS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: PURELIFT PRO PLUS
Company Name: Xtreem Pulse LLC

Primary DI Number: 00860008851031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079809275 *Terms of Use

Device Description: 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.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
66566	Facial muscle cosmesis electrical stimulator	An electrically-powered, hand-held device intended to be used in the home to apply electrical stimuli to the facial muscles through the skin (transcutaneously), to improve muscle tone and help tighten overlying skin for cosmetic facial rejuvenation. It includes electrodes at the distal end and controls to adjust the electrical impulse intensity; it is typically used with a gel, which may be supplied with the device, intended to facilitate conduction of the electrical current. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NFO	Stimulator, Transcutaneous Electrical, Aesthetic Purposes

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K221443	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Atmospheric Pressure: between 700 and 1060 KiloPascal
Handling Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between 10 and 45 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 20.7 Centimeter
Width: 4.8 Centimeter
Outer Diameter: 4.5 Centimeter

Device Record Status

Public Device Record Key: aa73e3e5-7077-496a-9747-857604488096
Public Version Date: October 09, 2023
Public Version Number: 1
DI Record Publish Date: September 30, 2023