Johari Digital Healthcare Ltd.

GUDID 08908008085352

truSculpt flex comprises a system console with touchscreen LCD and sixteen electrode handpieces, which deliver electrical impulses to the skin in direct proximity to the muscles to be stimulated. The electrical impulses are delivered in the subdermal muscular tissue area, triggering comforting and soothing muscle stimulation to achieve the intended use of strengthening, firming, and toning the muscles of the abdomen, thighs, and buttocks.

JOHARI DIGITAL HEALTHCARE LIMITED

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID08908008085352
NIH Device Record Key679d0f60-37af-4961-8319-6c97dde18e7e
Commercial Distribution StatusIn Commercial Distribution
Brand NameJohari Digital Healthcare Ltd.
Version Model NumbertruSculpt Flex retractable electrode assembly
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com
Phone982-805-4228
Emailsjohari@joharidigital.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108908008085352 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NGXStimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-10-23
Device Publish Date2019-08-02

On-Brand Devices [Johari Digital Healthcare Ltd.]

08908008085314Cranial Electrotherapy Stimulation(CES)
08908008085338Use for symptomatic relief and management of chronic pain and/or as adjunctive treatment in the
08908008085345truSculpt flex comprises a system console with touchscreen LCD and sixteen electrode handpieces,
08908008085352truSculpt flex comprises a system console with touchscreen LCD and sixteen electrode handpieces,
08908008085369MYOLIFT QT is a device based on true micro-current technology and one of the most advanced perso
08908008085383STIM TENS is cranial electrotherapy device and it provides powerful, predictable, proven stress
08908008085376600 is the latest True Microcurrent machine designed for professional use. Delivering true inte
08908008085406Mindgear is cranial electrotherapy device and it is indicated for use CES for the treatment of i
08908008085420"This device is a clinical combination therapy of Ultrasound & Electrotherapy with an easy user
08908008085413"This device is a clinical combination therapy of Ultrasound & Electrotherapy with an easy user
08908008085437"MYOLIFT Triwave is a device based on true micro-current technology and one of the most advanced
08908008085444Myolift 600+ delivers True Microcurrent for Facial Toning and Firming. Its gentle, non-invasive
08908008085451truFlex comprises a system console with a touchscreen LCD and sixteen electrode handpieces, whi
08908008085468"The Zeta Cranial Navigation System Is A Stereotaxic Image Guidance System Intended For The Spat

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.