Johari Digital Healthcare Ltd.

Basic Information

• Brand Name: Johari Digital Healthcare Ltd.
• Primary DI: 08908008085413
• Version / Model: Sonicaor Plus 921
• Company Name: JOHARI DIGITAL HEALTHCARE LIMITED
• Labeler DUNS: 675938472
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-06-04
• Public Version: 2
• Public Version Date: 2023-06-02
• Public Version Status: Update
• Public Device Record Key: 70576fb1-d9bb-48d6-8e76-e6a70e107207

Device Description

"This device is a clinical combination therapy of Ultrasound & Electrotherapy with an easy user interface and versatility to treat different body areas simultaneously. This aesthetically designed clinical model is lightweight, small in size, and is battery powered Precise treatment for pain relief Relaxation of muscle spasm Prevention of redardation of disuse atrophy Increase local blood circulation muscle re-education maintaining or increasing range of motion prevent venous thrombosis after surgery. Key Feature: • Channel : Two(921) Electrotherapy • 1 & 3 MHz Ultrasound Applicator • Large Color Touch Screen Display • Pre-programmed Protocols • Inbuilt Rechargeable Battery Pack"

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: No
• 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
IMG	Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	Physical Medicine	890.5860	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	08908008085413	GS1

Customer Contacts

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