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K Number
K003059

Validate with FDA (Live)

Device Name
LASER 4SPSC340
Manufacturer
PRIDE MOBILITY PRODUCTS CORP.
Date Cleared
2001-03-01

(150 days)

Product Code
INI
Regulation Number
890.3800
Type
Traditional
Panel
Physical Medicine
Age Range
N/A
Reference & Predicate Devices
N/A
Predicate For
K030387
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

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§ 890.3800 Motorized three-wheeled vehicle.

(a)
Identification. A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons.(b)
Classification. Class II (performance standards).