Johari Digital Healthcare Ltd.

Basic Information

• Brand Name: Johari Digital Healthcare Ltd.
• Primary DI: 08908008085345
• Version / Model: truSculpt Flex
• Company Name: JOHARI DIGITAL HEALTHCARE LIMITED
• Labeler DUNS: 675938472
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-06-21
• Public Version: 6
• Public Version Date: 2023-08-25
• Public Version Status: Update
• Public Device Record Key: 1e8dcd81-37fd-4f56-aef9-5e5b050477cf

Device Description

truFlex comprises a system console with a touchscreen LCD and sixteen electrode handpieces, which deliver electrical impulses to the skin in direct proximity to the muscles to be stimulated. The electrical impulses are delivered in the subdermal muscular tissue area, triggering comforting and soothing muscle stimulation to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• 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	Medical Specialty	Regulation #	Device Class
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	890.5850	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08908008085345	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K131291	000
K212866	000