AccessGUDID - DEVICE: Johari Digital Healthcare Ltd. (08908008085338)

GUDID

Device Identifier (DI) Information

Brand Name: Johari Digital Healthcare Ltd.
Version or Model: IF4250D
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: JOHARI DIGITAL HEALTHCARE LIMITED

Primary DI Number: 08908008085338
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 675938472 *Terms of Use

Device Description: Use for symptomatic relief and management of chronic pain and/or as adjunctive treatment in the management of post-surgical and posttraumatic acute pain. The device produces beat frequency of the range 1-250 Hz. The IF-4250D delivers very precise and repeatable Interferential therapy. Device is engineered by using ultra low power micro controller for precision, safety, durability and reliability. Key Features: 510(k) cleared device, Customizable program

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IPF	Stimulator, Muscle, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K024036	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8a8e66b0-0032-46d2-bfbf-3cdbdafe0a3d
Public Version Date: June 02, 2023
Public Version Number: 5
DI Record Publish Date: June 14, 2019