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510(k) Data Aggregation
K Number
K241193Device Name
AGILIS - Multi-function Physical Therapy Table (Model: Plus, Pro and Basic.)
Manufacturer
Marzzan Lucas Jorge
Date Cleared
2025-01-31
(277 days)
Product Code
JFB
Regulation Number
890.5880Why did this record match?
Applicant Name (Manufacturer) :
Marzzan Lucas Jorge
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AGILIS is a Multi-function physical therapy tables intended for medical purposes that consists of a motorized table which can be equipped to provide patients with powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.
Device Description
The AGILIS multifunction physiotherapy table and its line of models (Plus, Pro and Basic) are devices intended to provide patients with powered distraction, powered flexion, and muscle relaxation therapy. Neither device provides heat therapies.
The devices of the AGILIS line are made up of different modules articulated with each other, which provide movements and regulations for the manipulations carried out by the professional. The movements are divided according to the type of operation: manual or electric.
Manual operation systems:
- . Headpiece.
- . Extension of feet.
- Drops. .
- Dorso - lumbar release/breakaway
- Lateral Flexion. ●
Electrical operating systems:
- . Horizontal elevation.
- . Flexion of the lower limb sector.
- Extension or linear movement of the lower limb sector (distraction/traction).
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