K213078 is an FDA 510(k) clearance for the Myolift QT. This device is classified as a Stimulator, Transcutaneous Electrical, Aesthetic Purposes (Class II - Special Controls, product code NFO).
Submitted by Johari Digital Healthcare Limited (Jodhpur, IN). The FDA issued a Cleared decision on April 27, 2023, 581 days after receiving the submission on September 23, 2021.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 882.5890.
| 510(k) Number | K213078 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 23, 2021 |
| Decision Date | April 27, 2023 |
| Days to Decision | 581 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | NFO - Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5890 |