Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZ
FDA 510(k) K131309 · Ibramed Equipamentos Medicos
510(k) numberK131309
Submission
- Device name
- Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZ
- Applicant
- Ibramed Equipamentos Medicos
Aventura, FL, US - Received
- May 7, 2013
- Decision date
- January 27, 2014
- 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
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Questions and answers
When was Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZ cleared by the FDA?
Sonopulse Compact 1MHZ, Sonopulse Compact 3MHZ (K131309) received a 510(k) decision of Substantially Equivalent on January 27, 2014, 265 days after the submission was received.
What is the product code of K131309?
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.