The following data is part of a premarket notification filed by Johari Digital Healthcare Limited with the FDA for Trusculpt Flex.
Device ID | K212866 |
510k Number | K212866 |
Device Name: | TruSculpt Flex |
Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant | Johari Digital Healthcare Limited G-582, 584 EPIP, Boranda Jodhpur, IN 342012 |
Contact | Pooja Johari |
Correspondent | Pooja Johari Johari Digital Healthcare Limited G-582, 584 EPIP, Boranda Jodhpur, IN 342012 |
Product Code | NGX |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-09-08 |
Decision Date | 2022-12-03 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08908008085451 | K212866 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TRUSCULPT FLEX 97109617 not registered Live/Pending |
Cutera, Inc. 2021-11-04 |