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Product Classification

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Device

elevator, wheelchair, portable

Regulation Description

Wheelchair elevator.

Definition

A motorized lift device that is not permanently mounted in one location and that is intended for medical purposes to provide a means to move a person with impaired mobility, with or without a wheelchair, from one level to another (e.G., portable platform lifts, attendant-operated stair climbing devices for wheelchairs).

Regulation Medical Specialty

Physical Medicine

Review Panel

Physical Medicine

Product Code

ING

Submission Type

510(k)

Regulation Number

890.3930

Device Class

2

Total Product Life Cycle (TPLC)

TPLC Product Code Report

GMP Exempt?

No

Recognized Consensus Standards

ISO 7176-11:1992 Wheelchairs - Part 11: Test dummies
ISO 7176-13:1989 Wheelchairs - Part 13: Determination of coefficient of friction of test surfaces
ISO 7176-15:1996 Wheelchairs - Part 15: Requirements for information disclosure, documentation and labelling
ISO 7176-16:1997 Wheelchairs - Part 16: Resistance to ignition of upholstered parts -- Requirements and test methods
ISO 7176-6:2001 Wheelchairs - Part 6: Determination of maximum speed, acceleration and deceleration of electric wheelchairs
ISO 7176-3:2003 Wheelchairs - Part 3: Determination of effectiveness of brakes
ISO 7176-1:1999 Wheelchairs - Part 1: Determination of static stability
ISO 7176-2:2001 Wheelchairs - Part 2: Determination of dynamic stability of electric wheelchairs
ISO 7176-4:2008 Wheelchairs - Part 4: Energy consumption of electric wheelchairs and scooters for determination of theoretical distance range
ISO 7176-5:2008 Wheelchairs - Part 5: Determination of overall dimensions, mass and manoeuvring space
ISO 7176-10:2008 Wheelchairs - Part 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ISO 7176-14:2008 Wheelchairs - Part 14: Power and control systems for electrically powered wheelchairs and scooters - Requirements and test methods
ISO 7176-21:2009 Wheelchairs - Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers
ISO 7176-9: Third edition 2009-11-15 Wheelchairs - Part 9: Climatic tests for electric wheelchairs
ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 1 Determination of static stability
ANSI/RESNA WC-2:2009 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 2: Determination of dynamic stability of electrically powered wheelchairs
ANSI/RESNA WC-2:2009 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 3: Determination of effectiveness of brakes
ANSI/RESNA WC-2:2009 Section 4: Energy consumption of electrically powered wheelchairs and scooters for determination of theoretical dis
ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 5: Determination of dimensions, mass and maneuvering space
ANSI/RESNA WC-2:2009 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 6: Determination of maximum speed, acceleration and deceleration of electrically powered wheelchairs
ANSI/RESNA
ANSI/RESNA
ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs ¿ Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 7: Method of Measurement of Seating and Wheel Dimensions
ANSI/RESNA
ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 8: Requirements and test methods for static, impact and fatigue strengths
ANSI/RESNA
ANSI/RESNA WC-2:2009 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 9: Climatic tests for electrically powered wheelchairs
ANSI/RESNA
ANSI/RESNA WC-2:2009 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 10: Determination of obstacle-climbing ability of electrically powered wheelchairs
ANSI/RESNA
ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 11: Test dummies
ANSI/RESNA
ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 13: Determination of coefficient of friction of test surfaces
ANSI/RESNA
ANSI/RESNA WC-2:2009 American National Standard for Wheelchairs - Volume 2: Additional Requirements for Wheelchairs (including Scooters) with Electrical Systems Section 14: Power and control systems for electrically powered wheelchairs ¿ Requirements and test methods
ANSI/RESNA
ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 15: Requirements for information disclosure, documentation and labeling
ANSI/RESNA
ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 16: Resistance to ignition of upholstered parts - Requirements and test methods
ANSI/RESNA
ANSI/RESNA
ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelschairs (including Scooters) Section 22: Set-up procedures
ANSI/RESNA
ANSI/RESNA WC-2:2009 Section 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and
ASME
ANSI/RESNA WC-1:2009 American National Standard for Wheelchairs - Volume 1: Requirements and Test Methods for Wheelchairs (including Scooters) Section 26: Vocabulary
A18.1-2011 (Revision of ASME A18.1-2008) Safety Standard for Platform Lifts and Stairway Chairlifts

Third Party Review

Eligible for Accredited Persons Expansion Pilot Program

Accredited Persons

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