Cleared Traditional

K253340 - Electric Wheelchair (AL-208S-063) (FDA 510(k) Clearance)

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

K253340 · Zhongshan A&J Medical Equipment Co., Ltd. · Physical Medicine device
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Apr 2026
Decision
185d
Days
Class 2
Risk

K253340 is an FDA 510(k) clearance for the Electric Wheelchair (AL-208S-063). Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Zhongshan A&J Medical Equipment Co., Ltd. (Zhongshan, CN). The FDA issued a Cleared decision on April 3, 2026 after a review of 185 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Zhongshan A&J Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K253340 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2025
Decision Date April 03, 2026
Days to Decision 185 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
70d slower than avg
Panel avg: 115d · This submission: 185d
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 Peers - ITI Wheelchair, Powered

All 574
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K253340.
Power Wheelchair (N5919 series)
K253806 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Apr 2026
Power Wheelchair (OS-R-M01S)
K253952 · Beijing OrionStar Technology Co., Ltd. · Apr 2026
Electric wheelchair
K253307 · Foshan Dahao Medical Technology Co., Ltd. · Mar 2026
Electrically Powered Wheelchair (Model YC-01)
K253980 · Yurob Rehabilitation Medical Co., Ltd. · Mar 2026
Power wheelchair (ZS-EW8026)
K254206 · Ningbo Zhishan Medical Technology Co., Ltd. · Mar 2026
Electric Wheelchair (E201)
K254012 · Nanjing CareMoving Rehabilitation Equipment Co.,Ltd · Mar 2026