Cleared Traditional

AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)

K241193 · Marzzan Lucas Jorge · Physical Medicine

Jan 2025

Decision

277d

Days

Class 2

Risk

About This 510(k) Submission

K241193 is an FDA 510(k) clearance for the AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.), a Table, Physical Therapy, Multi Function (Class II — Special Controls, product code JFB), submitted by Marzzan Lucas Jorge (Rosario, AR). The FDA issued a Cleared decision on January 31, 2025, 277 days after receiving the submission on April 29, 2024. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5880.

Submission Details

510(k) Number	K241193 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 29, 2024
Decision Date	January 31, 2025
Days to Decision	277 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF