510(k) K241193
K241193 is an FDA 510(k) premarket notification submitted by Marzzan Lucas Jorge for the device "AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)". The FDA issued a decision of Substantially Equivalent on January 31, 2025. The device falls under product code JFB (Table, Physical Therapy, Multi Function), a Class II device regulated under 21 CFR 890.5880.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 31, 2025
- Date Received
- April 29, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Physical Therapy, Multi Function
- Device Class
- Class II
- Regulation Number
- 890.5880
- Review Panel
- PM
- Submission Type