Cleared Traditional

K240255 - Electric Wheelchair (JLE-W01A-2023)

K240255 is an FDA 510(k) clearance for Electric Wheelchair (JLE-W01A-2023), manufactured by Zhejiang Jianrui Technology Company Limited. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K240255 · Zhejiang Jianrui Technology Company Limited · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2024
Decision
189d
Days
Class 2
Risk

K240255 is an FDA 510(k) clearance for the Electric Wheelchair (JLE-W01A-2023). Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Zhejiang Jianrui Technology Company Limited (Jinhua, CN). The FDA issued a Cleared decision on August 7, 2024 after a review of 189 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 Jianrui Technology Company Limited devices

FDA 510(k) Submission Details - K240255

510(k) Number K240255 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 2024
Decision Date August 07, 2024
Days to Decision 189 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
74d slower than avg
Panel avg: 115d · This submission: 189d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

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 220
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K240255.
Electric wheelchair (S7018)
K240270 · Guangdong Prestige Technology Company Limited · Aug 2024
Power wheelchair (N6101)
K241686 · Zhejiang Zhonglei Medical Technology Co. , Ltd. · Aug 2024
Electric Wheelchair (Panda 10)
K240079 · Suzhou Ideal Medical Co., Ltd. · Aug 2024
Electric Wheelchair (Robooter E60) (BBR-E60-01)
K240339 · Shanghai Bangbang Robotics Co., Ltd. · Jul 2024
Electric Wheelchair (MP201C)
K241463 · Suzhou Master Machinery Manufacturing Co.,Ltd · Jul 2024
Electric Wheelchair (YFWB-63)
K241154 · If Health (Xiamen) Intelligent Technology Co.,Ltd · Jun 2024