Stairfriend Curved Stairway Chairlift

FDA 510(k) K023852 · Services Industriels Savaria, Inc.

Substantially Equivalent

510(k) numberK023852

Submission

Device name
Stairfriend Curved Stairway Chairlift
Applicant
Services Industriels Savaria, Inc.
Washington, DC, US
Received
November 19, 2002
Decision date
March 4, 2003
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ILK – Transport, Patient, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.5150
Specialty
Physical Medicine

A powered patient transport is a motorized device intended for use in mitigating mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs (e.g., attendant-operated portable stair-climbing chairs). This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.

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More from Summit Harmar, LLC

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K024346The MultiliftING · Traditional 03/04/2003SE
K024345B.07 Stairway ChairliftILK · Traditional 02/26/2003SE
K024167Step-Saver Stairway ChairliftILK · Traditional 02/06/2003SE
K960276Wheelchair ElevatorING · Traditional 04/01/1996SE

Questions and answers

When was Stairfriend Curved Stairway Chairlift cleared by the FDA?

Stairfriend Curved Stairway Chairlift (K023852) received a 510(k) decision of Substantially Equivalent on March 4, 2003, 105 days after the submission was received.

What is the product code of K023852?

The FDA product code is ILK – Transport, Patient, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5150.