Solace Lifesciences, Inc

GUDID 08908008085086

JOHARI DIGITAL HEALTHCARE LIMITED

Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use Transcutaneous electrical stimulation electrode, single-use

• Primary Device ID: 08908008085086
• NIH Device Record Key: 96c311f1-8246-4b34-aa93-2ad0cfdfef38
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Solace Lifesciences, Inc
• Version Model Number: NUCALM
• 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	08908008085086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K090052

FDA Product Code

• QJQ: Cranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-11-04
• Device Publish Date: 2016-09-19

Devices Manufactured by JOHARI DIGITAL HEALTHCARE LIMITED

• 08908008085468 - Johari Digital Healthcare Ltd.: 2024-02-02 "The Zeta Cranial Navigation System Is A Stereotaxic Image Guidance System Intended For The Spatial Positioning And Orientation
• 08908008085451 - Johari Digital Healthcare Ltd.: 2024-02-01 truFlex comprises a system console with a touchscreen LCD and sixteen electrode handpieces, which deliver electrical impulses t
• 08908008085444 - Johari Digital Healthcare Ltd.: 2023-12-12 Myolift 600+ delivers True Microcurrent for Facial Toning and Firming. Its gentle, non-invasive electrical impulses are evenly c
• 08908008085437 - Johari Digital Healthcare Ltd.: 2023-03-27 "MYOLIFT Triwave is a device based on true micro-current technology and one of the most advanced personal facial toning devices
• 08908008085000 - Johari Digital Healthcare Limited: 2021-12-27
• 08908008085017 - Johari Digital Healthcare Limited: 2021-12-27
• 08908008085024 - Johari Digital Healthcare Limited: 2021-12-27
• 08908008085031 - Johari Digital Healthcare Limited: 2021-12-27