Extreme X8

FDA 510(k) K211574 · Magic Mobility

Substantially Equivalent

510(k) numberK211574

Submission

Device name
Extreme X8
Applicant
Magic Mobility
Scoreby, AU
Received
May 21, 2021
Decision date
July 9, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
ITI – Wheelchair, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3860
Specialty
Physical Medicine

A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. FDA interprets “mobility to persons restricted to a sitting position” to mean the device type is intended to provide mobility to individuals who have mobility impairments and require an assistive device for mobility. NOTE: This type…

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Questions and answers

When was Extreme X8 cleared by the FDA?

Extreme X8 (K211574) received a 510(k) decision of Substantially Equivalent on July 9, 2021, 49 days after the submission was received.

What is the product code of K211574?

The FDA product code is ITI – Wheelchair, Powered, a Class II (moderate risk) device regulated under 21 CFR 890.3860.