Xpedition Powered Stair Chair (625700000000)
FDA 510(k) K222818 · Stryker Medical
510(k) numberK222818
Submission
- Device name
- Xpedition Powered Stair Chair (625700000000)
- Applicant
- Stryker Medical
Portage, MI, US - Received
- September 19, 2022
- Decision date
- January 24, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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Questions and answers
When was Xpedition Powered Stair Chair (625700000000) cleared by the FDA?
Xpedition Powered Stair Chair (625700000000) (K222818) received a 510(k) decision of Substantially Equivalent on January 24, 2023, 127 days after the submission was received.
What is the product code of K222818?
The FDA product code is ILK – Transport, Patient, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.5150.