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K Number
K973951
Device Name
LEVO COMPACT-EASY LCE
Manufacturer
LEVO USA
Date Cleared
1997-12-23

(68 days)

Product Code
IPL
Regulation Number
890.3900
Type
Traditional
Panel
PM
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The LEVO stand-up wheelchair is a product which changes position from seating to standing and standing to seating.
Target population: For whole those who need a wheelchair and can not stand on their on feet such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc..

Device Description

An electrical power suported stand-up mechanism is integrated in a manual driven wheelchair which allows the user to stand up easily when and where ever he wants to.
Material: Main frame: Colour painted aluminium. Major stressed parts: Reinforced brass casting. Uphoistery: Flame impeded. Battery: 2 Gel, sealed lead acid battery (12V/2.9Ah in series=24V/2.9Ah). Stand-up motor: Linak Power Drive LA 28.405-150-24-001 24 VDC, 2500N.

AI/ML Overview

This is a 510(k) clearance letter for the LEVO Compact-Easy LCE stand-up wheelchair, dated December 23, 1997. As such, it does not contain any information regarding acceptance criteria or a study proving the device meets those criteria, as these were not standard requirements for 510(k) submissions at that time.

The document merely states that the device is "substantially equivalent" to legally marketed predicate devices. It lists the indications for use, target population, design, material, and some performance characteristics, but these are descriptive and do not constitute acceptance criteria or results from a formal study.

Therefore, I cannot provide the requested information based on the provided text.
I can, however, extract the descriptive information about the device:

Device Name: LEVO compact-easy LCE

Indications For Use:

  • The LEVO stand-up wheelchair is a product which changes position from seating to standing and standing to seating.

Target population:

  • For those who need a wheelchair and cannot stand on their own feet, such as people with spinal cord injury, spina bifida, cerebral palsy, multiple sclerosis, muscular dystrophy, polio, rheumatism, etc.

Design:

  • An electrical power supported stand-up mechanism is integrated into a manual driven wheelchair which allows the user to stand up easily when and wherever he wants to.

Material:

  • Main frame: Colour painted aluminium.
  • Major stressed parts: Reinforced brass casting.
  • Upholstery: Flame impeded.
  • Battery: 2 Gel, sealed lead acid battery (12V/2.9Ah in series = 24V/2.9Ah)
  • Stand-up motor: Linak Power Drive LA 28.405-150-24-001 24 VDC, 2500N

Performance (descriptive, not quantified):

  • The LEVO compact easy LCE allows the user to stand up easily when and wherever he wants to. Whether to reach things without help of others, whether take part in discussions standing up and show influence, whether just to do daily therapy individually.

§ 890.3900 Standup wheelchair.

(a)
Identification. A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.(b)
Classification. Class II (performance standards).