Cleared Traditional

Electric wheelchair (YHW001-C (K240329) - FDA 510(k) Clearance

Also marketed or referenced as:
YHW001-D YHW001-E YHW001-F)

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

K240329 · Yongkang Youha Electric Appliance Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
49d
Days
Class 2
Risk

K240329 is an FDA 510(k) clearance for the Electric wheelchair (YHW001-C. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Yongkang Youha Electric Appliance Co., Ltd. (Yongkang, CN). The FDA issued a Cleared decision on March 25, 2024 after a review of 49 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 Yongkang Youha Electric Appliance Co., Ltd. devices

Submission Details

510(k) Number K240329 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 2024
Decision Date March 25, 2024
Days to Decision 49 days
Submission Type Traditional
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
66d faster than avg
Panel avg: 115d · This submission: 49d
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 K240329.
Electric Wheelchair (YFWB-63)
K241154 · If Health (Xiamen) Intelligent Technology Co.,Ltd · Jun 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
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