Johari Digital Healthcare Ltd. - "This device is a clinical combination therapy of - JOHARI DIGITAL HEALTHCARE LIMITED

Duns Number:675938472

Device Description: "This device is a clinical combination therapy of Ultrasound & Electrotherapy with an easy "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 : Four(941) Electrotherapy • 1 & 3 MHz Ultrasound Applicator • Large Color Touch Screen Display • Pre-programmed Protocols • Inbuilt Rechargeable Battery Pack"

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More Product Details

Catalog Number

-

Brand Name

Johari Digital Healthcare Ltd.

Version/Model Number

Sonicaor Plus 941

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

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)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

IMG

Product Code Name

Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat

Device Record Status

Public Device Record Key

c4cb5679-1dc3-4781-9e8c-99336bc1ba54

Public Version Date

June 14, 2021

Public Version Number

1

DI Record Publish Date

June 04, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"JOHARI DIGITAL HEALTHCARE LIMITED" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 41
3 A medical device with high risk that requires premarket approval 1