Cleared Traditional

K052375 - ALILIFE STAND UP POWERED WHEELCHAIR, HC-300

K052375 is an FDA 510(k) clearance for ALILIFE STAND UP POWERED WHEELCHAIR, manufactured by Alilife Technological Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K052375 · Alilife Technological Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2005
Decision
10d
Days
Class 2
Risk

K052375 is an FDA 510(k) clearance for the ALILIFE STAND UP POWERED WHEELCHAIR, HC-300. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Alilife Technological Co., Ltd. (Hsin-Chu City, TW). The FDA issued a Cleared decision on September 9, 2005 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3900 - 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 Alilife Technological Co., Ltd. devices

FDA 510(k) Submission Details - K052375

510(k) Number K052375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2005
Decision Date September 09, 2005
Days to Decision 10 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
105d faster than avg
Panel avg: 115d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPL Device Classification - Class 2, Special Controls

Product Code IPL Wheelchair, Standup
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3900
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 - IPL Wheelchair, Standup

All 23
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K052375.
Modular Power Standing System
K191376 · Motion Concepts · Aug 2019
Quickie(r) Q700-UP M
K172384 · Sunrise Medical (Us), LLC · Jan 2018
Action Trackstander models TR1816, TR1820, TR2016, and TR2020
K163451 · Action Manufacturing, Inc. · Jan 2018
STANNAH POWER CHAIR, MODEL 201
K994083 · Stannah Power Chairs , Ltd. · Apr 2001
THE LIBERATOR
K984391 · Liberator Wheelchairs, Inc. · Sep 1999
LEVO MOBIL LCM
K963817 · Levo USA · Dec 1997