Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Magic Mobility. It received FDA 510(k) clearance on 2021-07-09 under 510(k) 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. The listed applicant is Magic Mobility. The 510(k) number is K211574.

When did Extreme X8 receive FDA 510(k) clearance?

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

Who is the listed applicant for Extreme X8?

The FDA 510(k) record lists Magic Mobility as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Extreme X8?

The FDA product code for Extreme X8 is ITI.

Other records listing Magic Mobility as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233877XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)K213090Frontier Series Power WheelchairsK203083Magic 360 Power Wheelchair

Related Devices (Code: ITI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261149Electric Wheelchair (DY611A-2, DY612A-1)Zhejiang Lumbre Electric Appliance Co., Ltd.K261396Electric WheelchairNingbo Resshidi Medical Devices Co., Ltd.K261164Electric wheelchair (XW-LY007 )Yongkang Ruihe Metal Product Co., Ltd.K260937Smart Electric Wheelchair (R1-Std-BK, R1-Pro-BK, R1-Ultra-GK, R1-Ultra-WK)Shanghai Waylong Intelligent Technology Co.,LtdK253812Power Wheelchair (W5915B, W5915C, W5915D)Zhejiang Innuovo Rehabilitation Devices Co.,LtdK260335Electric Wheelchair (S500-6)Zhongshan Sulenz Intelligent Technology Co., Ltd.

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.

↑