AccessGUDID - DEVICE: Syrma Johari MedTech Limited (08908008085499)

GUDID

Device Identifier (DI) Information

Brand Name: Syrma Johari MedTech Limited
Version or Model: Myolift QT+
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SYRMA JOHARI MEDTECH LIMITED

Primary DI Number: 08908008085499
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 675938472 *Terms of Use

Device Description: "The Myolift QT+ is a Microcurrent, handheld, and mobile application based device, and easy to operate. The application used with this device will support both the types of users iPhone® and Android™. The User has to download the application via Google Play™ store (Android) /App Store® (iOS) and connect the device via Bluetooth of their phone and make their profiles accordingly. The purpose of this device is to lift and tone the face and neck. It is a battery-powered device used with conductive gel. The conductive gel is used to reduce the impedance between the electrodes and the skin of the user. Myolift QT+ has one channel and two output ports. One output is through the applicator ball and the other output is through the lead wire via the USB port connected through the charging port"

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?
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 [?]
K213078	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: 728df027-bec3-418b-9964-1b98500fa5e0
Public Version Date: July 16, 2025
Public Version Number: 1
DI Record Publish Date: July 08, 2025