Johari Digital Healthcare Ltd.

GUDID 08908008085475

"MyoBody XT is a sleek, multifunctional colored touch screen LCD desktop device. The device provides electrical muscle stimulation, interferential muscle stimulation, premod stimulation through four outputs. User can easily select any of the modes by one touch through the colored touch screen LCD display which displays selectable treatments, outputs, treatment time and intensity (that is controlled by a large knob) with START, STOP and PAUSE buttons. The colors of the screen and the buttons in it reflect whether the treatment is going on while constantly displaying the balance treatment time. intensity (that is controlled by a large knob) with START, STOP and PAUSE buttons. The colors of the screen and the buttons in it reflect whether the treatment is going on while constantly displaying the balance treatment time. "

JOHARI DIGITAL HEALTHCARE LIMITED

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 08908008085475
• NIH Device Record Key: 97fdef2c-9d61-4831-ae80-415280b2b4a4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Johari Digital Healthcare Ltd.
• Version Model Number: MyoBody XT
• Company DUNS: 675938472
• Company Name: JOHARI DIGITAL HEALTHCARE LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08908008085475 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131291

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-02-12
• Device Publish Date: 2025-02-04

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