TruSculpt Flex

Stimulator, Muscle, Powered, For Muscle Conditioning

Johari Digital Healthcare Limited

The following data is part of a premarket notification filed by Johari Digital Healthcare Limited with the FDA for Trusculpt Flex.

Pre-market Notification Details

Device IDK212866
510k NumberK212866
Device Name:TruSculpt Flex
ClassificationStimulator, Muscle, Powered, For Muscle Conditioning
Applicant Johari Digital Healthcare Limited G-582, 584 EPIP, Boranda Jodhpur,  IN 342012
ContactPooja Johari
CorrespondentPooja Johari
Johari Digital Healthcare Limited G-582, 584 EPIP, Boranda Jodhpur,  IN 342012
Product CodeNGX  
CFR Regulation Number890.5850 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-08
Decision Date2022-12-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08908008085451 K212866 000

Trademark Results [TruSculpt Flex]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRUSCULPT FLEX
TRUSCULPT FLEX
97109617 not registered Live/Pending
Cutera, Inc.
2021-11-04

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