Cleared Abbreviated

MERITS MODEL P322FWD POWERED WHEELCHAIR (K122357) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K122357 · Merits Health Products Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
159d
Days
Class 2
Risk

K122357 is an FDA 510(k) clearance for the MERITS MODEL P322FWD POWERED WHEELCHAIR. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Merits Health Products Co., Ltd. (Taichung, TW). The FDA issued a Cleared decision on January 9, 2013 after a review of 159 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Merits Health Products Co., Ltd. devices

Submission Details

510(k) Number K122357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 2012
Decision Date January 09, 2013
Days to Decision 159 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d slower than avg
Panel avg: 115d · This submission: 159d
Pathway characteristics
Standards-based clearance path.

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 171
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K122357.
HEARTWAY Electrically Powered Wheelchair P27
K142783 · Heartway Medical Products Co., Ltd. · Jun 2015
HEARTWAY Electrically Powered Wheelchairs
K142731 · Heartway Medical Products Co., Ltd. · Feb 2015
TDX SP2 POWER WHEECHAIR
K141783 · Invacare Corporation · Jan 2015
INVACARE 3G TARSYS
K033819 · Invacare Corp. · Jun 2004
STORM TDX POWER WHEELCHAIR
K023589 · Invacare Corp. · Nov 2002
INVACARE POWERED WHEELCHAIRS, MODELS M50, M51, M71 & M91
K021680 · Invacare Corp. · Jun 2002