Duns Number:675938472
Device Description: MYOLIFT QT is a device based on true micro-current technology and one of the most advanced MYOLIFT QT is a device based on true micro-current technology and one of the most advanced personal facial toning devices on the market. Its gentle, non-invasive electrical impulses are evenly channelled to the facial muscles through two applicator probes, re-educating & strengthening the muscle. MYOLIFT QT is portable device powered from the built-in battery or external power supply. The battery charger which is the integral part of device provides the fast and effective charging process. MYOLIFT QT is a portable device with Blue-Tooth (BT) connectivity with simple user- interface where the full control of device is provided through BT. Some simple actions and major indications can be achieved by using the interfaces which are built-in in device
Catalog Number
-
Brand Name
Johari Digital Healthcare Ltd.
Version/Model Number
Myolift QT
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112351
Product Code
NFO
Product Code Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Public Device Record Key
cc81fccd-89a1-45dc-82c3-916443e1bc0f
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
October 02, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |
| 3 | A medical device with high risk that requires premarket approval | 1 |