AccessGUDID - DEVICE: Johari Digital Healthcare Ltd. (08908008085376)

GUDID

Device Identifier (DI) Information

Brand Name: Johari Digital Healthcare Ltd.
Version or Model: Myolift 600
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JOHARI DIGITAL HEALTHCARE LIMITED

Primary DI Number: 08908008085376
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 675938472 *Terms of Use

Device Description: 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.

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):	No
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?
46573	Physical therapy transcutaneous neuromuscular electrical stimulation system	An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.	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 [?]
K112351	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 25525fdc-dd0f-4b4f-9c68-f3cfc8a8dd2d
Public Version Date: June 02, 2023
Public Version Number: 3
DI Record Publish Date: October 30, 2020