The following data is part of a premarket notification filed by Ibramed- Industria Brazileria De Equipamentos Medi with the FDA for Sonopulse/ Sonopulse Iii.
| Device ID | K130888 |
| 510k Number | K130888 |
| Device Name: | SONOPULSE/ SONOPULSE III |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | IBRAMED- INDUSTRIA BRAZILERIA DE EQUIPAMENTOS MEDI 18851 NE 29TH AVE, 720 Aventura, FL 33180 |
| Contact | Tara Conrad |
| Correspondent | Tara Conrad IBRAMED- INDUSTRIA BRAZILERIA DE EQUIPAMENTOS MEDI 18851 NE 29TH AVE, 720 Aventura, FL 33180 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-29 |
| Decision Date | 2014-01-09 |
| Summary: | summary |