Cleared Traditional

Electric Wheelchair (YFWB-63) (K241154) - FDA 510(k) Clearance

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

K241154 · If Health (Xiamen) Intelligent Technology Co.,Ltd · Physical Medicine device
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Jun 2024
Decision
63d
Days
Class 2
Risk

K241154 is an FDA 510(k) clearance for the Electric Wheelchair (YFWB-63). Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by If Health (Xiamen) Intelligent Technology Co.,Ltd (Xiamen, CN). The FDA issued a Cleared decision on June 28, 2024 after a review of 63 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 If Health (Xiamen) Intelligent Technology Co.,Ltd devices

Submission Details

510(k) Number K241154 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 2024
Decision Date June 28, 2024
Days to Decision 63 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
52d faster than avg
Panel avg: 115d · This submission: 63d
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 170
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K241154.
Electric Wheelchair (JLE-W01A-2023)
K240255 · Zhejiang Jianrui Technology Company Limited · 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
K240673 · Zhejiang Hfizer Medical Equipment Co., Ltd. · Jun 2024
Electric Wheelchair (HBLD3-B)
K240913 · Shanghai Hubang Intelligent Rehabilitation Equipment Co.,Ltd · May 2024
Electric wheelchair (YHW001-C
K240329 · Yongkang Youha Electric Appliance Co., Ltd. · Mar 2024