SONOPULSE/ SONOPULSE III
FDA 510(k) clearance K130888 · decided 2014-01-09
Clearance details
- K-number
- K130888
- Device name
- SONOPULSE/ SONOPULSE III
- Applicant
- Ibramed- Industria Brazileria DE Equipamentos Medi
- Decision
- Substantially Equivalent
- Date received
- 2013-03-29
- Decision date
- 2014-01-09
- Days to decision
- 286 days
- Clearance type
- Traditional
- Product code
- IMI
- Device class
- 2
- Regulation number
- 890.5300
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Aventura, FL, US
- Third-party review
- No
- Expedited review
- No
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| JAS Pulse(TM) Ultrasonic Therapy (K161628) | Bonutti Research, Inc. | 2016-11-10 |
| Accent XL (K160075) | Alma Lasers, Inc. | 2016-08-17 |
| MC1 Plus (K161502) | General Project S.R.L. | 2016-08-16 |
| UltraTENS (K142976) | Shenzhen Dongdixin Technology Co., Ltd. | 2015-08-26 |
| SONOPULSE COMPACT 1MHZ, SONOPULSE COMPACT 3MHZ (K131309) | Ibramed Equipamentos Medicos | 2014-01-27 |
| ACCUSONIC ADVANTAGE (K124010) | Metron Medical Australia, Pty, Ltd. | 2013-08-23 |
Recalls involving this device
No recalls on record reference this clearance.