Cleared Traditional

Extreme X8 (K211574) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211574 · Magic Mobility · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2021
Decision
49d
Days
Class 2
Risk

K211574 is an FDA 510(k) clearance for the Extreme X8. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Magic Mobility (Scoreby, AU). The FDA issued a Cleared decision on July 9, 2021 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - the FDA physical medicine device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Magic Mobility devices

Submission Details

510(k) Number K211574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2021
Decision Date July 09, 2021
Days to Decision 49 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition 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 Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Consultant

Acknowledge Regulatory Strategies, LLC
Michelle Rubin-Onur

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ITI Wheelchair, Powered

All 139
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K211574.
Electrically Powered Wheelchair -Model HP358E
K201855 · Kunshan Hi-Fortune Health Products Co., Ltd. · Sep 2021
Electric Wheelchair (XW-LY001)
K200423 · Yongkang Dingchang Industry & Trade Co., Ltd. · Sep 2021
Electric Wheelchair [Models: JRWD6010/JRWD6012]
K192739 · Jerry Medical Instrument (Shanghai) Co., Ltd. · Jul 2021
JWX-1 Plus (Navigo 16/Navigo 24)
K203806 · Yamaha Motor Co., Ltd. · May 2021
Karma Powered Wheelchair
K202506 · Karma Medical Products Co., Ltd. · Apr 2021
Electric Wheelchair (Model: S7110)
K200978 · Dongguan Prestige Sporting Goods Co., Ltd. · Apr 2021