510(k) K131926
K131926 is an FDA 510(k) premarket notification submitted by Ibramed Equipamentos Medicos for the device "THERMOPULSE". The FDA issued a decision of Substantially Equivalent on Jul 24, 2014. The device falls under product code IMJ (Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat), a Class II device regulated under 21 CFR 890.5290. Ibramed Equipamentos Medicos has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 24, 2014
- Date Received
- Jun 26, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- Device Class
- Class II
- Regulation Number
- 890.5290
- Review Panel
- PM
- Submission Type