FDA UDI In Commercial Distribution 🇺🇸 United States

Syrma Johari MedTech Limited

DI: 08908008085499 · Model: Myolift QT+ · SYRMA JOHARI MEDTECH LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
Syrma Johari MedTech Limited
Primary DI
08908008085499
Version / Model
Myolift QT+
Company Name
SYRMA JOHARI MEDTECH LIMITED
Labeler DUNS
675938472
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2025-07-08
Public Version
1
Public Version Date
2025-07-16
Public Version Status
New
Public Device Record Key
728df027-bec3-418b-9964-1b98500fa5e0

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

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
Yes
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
No
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
Yes
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

GMDN Terms

Code Name
46573 Physical therapy transcutaneous neuromuscular electrical stimulation system

Identifiers

Type ID
Primary 08908008085499

Premarket Submissions

Submission Number Supplement Number
K213078 000