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"
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
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
IMG
Product Code Name
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
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 |