Cleared Special

K253806 - Power Wheelchair (N5919 series) (FDA 510(k) Clearance)

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K253806 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Physical Medicine device
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Apr 2026
Decision
143d
Days
Class 2
Risk

K253806 is an FDA 510(k) clearance for the Power Wheelchair (N5919 series). Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Zhejiang Innuovo Rehabilitation Devices Co.,Ltd (Dongyang, CN). The FDA issued a Cleared decision on April 20, 2026 after a review of 143 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Zhejiang Innuovo Rehabilitation Devices Co.,Ltd devices

Submission Details

510(k) Number K253806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2025
Decision Date April 20, 2026
Days to Decision 143 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 115d · This submission: 143d
Pathway characteristics
Modification to existing cleared device.

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

Shanghai SUNGO Management Consulting Co., Ltd.
Ivy Wang

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 574
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