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FDA 510(k)

Extreme X8

K-Number: K211574 · 2021-07-09

ApplicantMagic Mobility
Decision Date2021-07-09
Product CodeITI
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Extreme X8 is a medical device manufactured by Magic Mobility. It received FDA 510(k) clearance on 2021-07-09 under approval number K211574. The device is classified under product code ITI. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Extreme X8?

Extreme X8 is a medical device that received FDA 510(k) clearance on 2021-07-09. It is manufactured by Magic Mobility. The 510(k) number is K211574.

When was Extreme X8 approved by the FDA?

Extreme X8 received FDA 510(k) clearance on 2021-07-09, under approval number K211574.

What company makes Extreme X8?

Extreme X8 is manufactured by Magic Mobility.

What is the FDA product code for Extreme X8?

The FDA product code for Extreme X8 is ITI.

Other Devices by Magic Mobility

K213090Frontier Series Power Wheelchairs K203083Magic 360 Power Wheelchair K233877XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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