510(k) K241193

AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.) by Marzzan Lucas Jorge — Product Code JFB

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