Solace Lifesciences, Inc

GUDID 08908008085086

JOHARI DIGITAL HEALTHCARE LIMITED

Transcutaneous electrical stimulation electrode
Primary Device ID08908008085086
NIH Device Record Key96c311f1-8246-4b34-aa93-2ad0cfdfef38
Commercial Distribution StatusIn Commercial Distribution
Brand NameSolace Lifesciences, Inc
Version Model NumberNUCALM
Company DUNS675938472
Company NameJOHARI DIGITAL HEALTHCARE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108908008085086 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QJQCranial Electrotherapy Stimulator To Treat Insomnia And/Or Anxiety

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-11-04
Device Publish Date2016-09-19

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 Limited2021-12-27
08908008085017 - Johari Digital Healthcare Limited2021-12-27
08908008085024 - Johari Digital Healthcare Limited2021-12-27
08908008085031 - Johari Digital Healthcare Limited2021-12-27

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