The following data is part of a premarket notification filed by Mectronic Medicale S.r.l. with the FDA for Doctor Tecar.
| Device ID | K183693 |
| 510k Number | K183693 |
| Device Name: | Doctor Tecar |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | Mectronic Medicale S.r.l. Via Orio Al Serio, 15 Grassobbio, IT 24050 |
| Contact | Gloria Aloisini |
| Correspondent | Gloria Aloisini Mectronic Medicale S.r.l. Via Orio Al Serio, 15 Grassobbio, IT 24050 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-31 |
| Decision Date | 2019-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08051499970864 | K183693 | 000 |
| 08051499970161 | K183693 | 000 |