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 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08908008085451 | K212866 | 000 |
Trademark Results [TruSculpt Flex]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRUSCULPT FLEX 97109617 not registered Live/Pending |
Cutera, Inc. 2021-11-04 |
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