Duns Number:675938472
Device Description: 600 is the latest True Microcurrent machine designed for professional use. Delivering tru 600 is the latest True Microcurrent machine designed for professional use. Delivering true intensity ranging from 175 to 600 micro amps, this machine ignites the ATP stimulation and sets a standard for non-invasive technology and the ability to provide long-lasting, natural facial lifting and toning results. This powerful True Microcurrent machine is only for licensed cosmetologists, aesthetics, or acupuncturists. This microcurrent machine for professionals is a perfect tool for boosting ATP for anti-aging, cellular repair, muscle re-education, skin firmness and tightening.
Catalog Number
-
Brand Name
Johari Digital Healthcare Ltd.
Version/Model Number
Myolift 600
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"
-
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
25525fdc-dd0f-4b4f-9c68-f3cfc8a8dd2d
Public Version Date
February 19, 2021
Public Version Number
2
DI Record Publish Date
October 30, 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 |