Data / Medical devices / Italy / Mectronic Medicale S.R.L.
Mectronic Medicale S.R.L.: FDA-registered device maker in Grassobbio Bergamo, Italy, 2 510(k) clearances
Mectronic Medicale S.R.L. is registered with the FDA (registration 3015283772) in Grassobbio Bergamo, Italy. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 17, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015283772
- Address
- Via Orio al Serio, 15, Grassobbio Bergamo, Italy, 24050
- Owner or operator
- MECTRONIC MEDICALE S.R.L. (10059926)
- Roles
- Manufacturer
- First device listed
- March 10, 2019
- Registered through
- 2026
- Brand names listed
- CHELT, DOCTOR TECAR, Doctor Tecar Plus, Doctor Tecar Smart, Ixyon XP, iLux Light, iLux PLUS, iLux SMART, iLux XP
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 17, 2023 | K221043 | Doctor Tecar Plus, Doctor Tecar Smart | PBX | Substantially Equivalent | Mectronic Medicale S.R.L. | accessdata.fda.gov |
| February 22, 2019 | K183693 | Doctor Tecar | PBX | Substantially Equivalent | Mectronic Medicale S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Lamp, Infrared, Therapeutic Heating
Updated February 17, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.