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K Number
K040457
Device Name
NOMAD FROM DYNAMIS MOBILITY LTD.
Manufacturer
DYNAMIS MOBILITY LTD.
Date Cleared
2004-05-19

(86 days)

Product Code
ITI
Regulation Number
890.3860
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

INTENDED USE OF THE NOMA'S POWERED THE WHEELCHAIR IS TO PROVIDE SAFE PERSONAL HOBILITY TO PERSONS LIMITED TO A SEATED OPERATING A WITC ARE CAPABLE OF POSITION POWERED WHEELLHAIR

Device Description

Nomad Powered Wheelchair

AI/ML Overview

This is an FDA 510(k) clearance letter for a powered wheelchair (Nomad Powered Wheelchair, K040457). This type of document does not contain the information requested regarding acceptance criteria and formal study results for device performance.

FDA 510(k) clearances establish substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. They typically do not require the rigorous clinical trial data or detailed performance studies that would be submitted for a Pre-Market Approval (PMA) application or a de novo classification.

Therefore, I cannot provide the requested information. The document focuses on regulatory compliance and substantial equivalence, not detailed performance metrics and study designs as would be found in a clinical study report or a more extensive technical file.

§ 890.3860 Powered wheelchair.

(a)
Identification. A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class II (performance standards).