Sonomed IV, Sonomed V
FDA 510(k) K202788 · Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto
510(k) numberK202788
Submission
- Device name
- Sonomed IV, Sonomed V
- Applicant
- Carci Industria E Comercio DE Aparelhos Cirurgicos E Orto
Sao Paulo, BR - Received
- September 22, 2020
- Decision date
- December 23, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IMI – Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5300
- Specialty
- Physical Medicine
Other 510(k)s with product code IMI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240788 | Ultrasound StimulatorIMI · Traditional | Jkh Health Co., Ltd. | 06/04/2025SE |
| K230472 | Sonopuls 190IMI · Traditional | Enraf-Nonius, B.V. | 10/24/2023SE |
| K222098 | ManaSport+IMI · Traditional | Manamed, Inc. | 03/08/2023SE |
| K210284 | ManaSportIMI · Traditional | Manamed, Inc. | 04/26/2022SE |
| K160378 | BRH-A2 Combined Ultrasound and Electric Field Stimulation (CUSEFS)IMI · Traditional | Brh Medical , Ltd. | 08/25/2017SE |
| K161628 | JAS Pulse(TM) Ultrasonic TherapyIMI · Abbreviated | Bonutti Research, Inc. | 11/10/2016SE |
| K160075 | Accent XLIMI · Traditional | Alma Lasers, Inc. | 08/17/2016SE |
| K161502 | MC1 PlusIMI · Special | General Project S.R.L. | 08/16/2016SE |
| K142976 | UltraTENSIMI · Traditional | Shenzhen Dongdixin Technology Co., Ltd. | 08/26/2015SE |
| K131309 | Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZIMI · Traditional | Ibramed Equipamentos Medicos | 01/27/2014SE |
Questions and answers
When was Sonomed IV, Sonomed V cleared by the FDA?
Sonomed IV, Sonomed V (K202788) received a 510(k) decision of Substantially Equivalent on December 23, 2021, 457 days after the submission was received.
What is the product code of K202788?
The FDA product code is IMI – Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat, a Class II (moderate risk) device regulated under 21 CFR 890.5300.