Cleared Traditional

Power Wheelchair (N5909) (K230964) - FDA 510(k) Clearance

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

K230964 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Physical Medicine device
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Dec 2023
Decision
252d
Days
Class 2
Risk

K230964 is an FDA 510(k) clearance for the Power Wheelchair (N5909). 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 December 13, 2023 after a review of 252 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 Zhejiang Innuovo Rehabilitation Devices Co.,Ltd devices

Submission Details

510(k) Number K230964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 2023
Decision Date December 13, 2023
Days to Decision 252 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 115d · This submission: 252d
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 138
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K230964.
XT Series Power Wheelchair (XT2), XT Series Power Wheelchair (XT4)
K233877 · Magic Mobility · Mar 2024
Power wheelchair (Model: JMPW-01W)
K232783 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Jan 2024
Velox Power Chair
K231315 · Velox Manufacturing, Inc. · Jan 2024
Power Wheelchair, W5521
K231508 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Nov 2023
Electric Wheelchair (Robooter E40), Model name: BBR-E40-01
K231868 · Shanghai Bangbang Robotics Co., Ltd. · Oct 2023
Electrically Power Wheelchairs (Models:YLB-W-0812-A01, YLB-W-0812-A02, YLB-W-0812-A03)
K232193 · Yurob Rehabilitation Medical Co., Ltd. · Sep 2023