510(k) K221043
K221043 is an FDA 510(k) premarket notification submitted by Mectronic Medicale S.R.L. for the device "Doctor Tecar Plus, Doctor Tecar Smart". The FDA issued a decision of Substantially Equivalent on Feb 17, 2023. The device falls under product code PBX (Massager, Vacuum, Radio Frequency Induced Heat), a Class II device regulated under 21 CFR 878.4400. Mectronic Medicale S.R.L. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 17, 2023
- Date Received
- Apr 8, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Massager, Vacuum, Radio Frequency Induced Heat
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type
- 510(k)
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.