Cleared Traditional

K142027 - 888 WNLE POWERED WHEELCHAIR (FDA 510(k) Clearance)

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

K142027 · Pihsiang Machinery Mfg. Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
74d
Days
Class 2
Risk

K142027 is an FDA 510(k) clearance for the 888 WNLE POWERED WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Pihsiang Machinery Mfg. Co., Ltd. (Carson, US). The FDA issued a Cleared decision on October 7, 2014 after a review of 74 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 Pihsiang Machinery Mfg. Co., Ltd. devices

Submission Details

510(k) Number K142027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2014
Decision Date October 07, 2014
Days to Decision 74 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 115d · This submission: 74d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 575
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K142027.
Electric Wheelchair (Y207BL)
K253241 · Jiangsu Intco Medical Products Co., Ltd. · May 2026
Power Wheelchair (N5919 series)
K253806 · Zhejiang Innuovo Rehabilitation Devices Co.,Ltd · Apr 2026
Power Wheelchair (OS-R-M01S)
K253952 · Beijing OrionStar Technology Co., Ltd. · Apr 2026
Electric Wheelchair (AL-208S-063)
K253340 · Zhongshan A&J Medical Equipment Co., Ltd. · Apr 2026
Electric wheelchair
K253307 · Foshan Dahao Medical Technology Co., Ltd. · Mar 2026
Electrically Powered Wheelchair (Model YC-01)
K253980 · Yurob Rehabilitation Medical Co., Ltd. · Mar 2026