Cleared Traditional

K001923 - REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800

K001923 is an FDA 510(k) clearance for REGENCY POWER WHEELCHAIR, manufactured by Gendron, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K001923 · Gendron, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2000
Decision
63d
Days
Class 2
Risk

K001923 is an FDA 510(k) clearance for the REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Gendron, Inc. (Archbold, US). The FDA issued a Cleared decision on August 25, 2000 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 Gendron, Inc. devices

FDA 510(k) Submission Details - K001923

510(k) Number K001923 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 2000
Decision Date August 25, 2000
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.

ITI Device Classification - Class 2, Special Controls

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 376
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K001923.
TRAX, POWERED WHEELCHAIR, MODEL 308686-00-0
K993406 · Permobil AB · Dec 2000
QUICKIE 2 POWER ASSIST WHEELCHAIR
K001491 · Sunrise Medical, Inc. · Dec 2000
JET 1 POWERED WHEELCHAIR
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RANGER II M6, MODEL IN-888WNL
K002157 · Invacare Corp. · Aug 2000
MODEL CGS TILT SEATING SYSTEM FOR POWER WHEELCHAIRS
K001777 · Invacare Corp. · Jul 2000
T-2000-POWER TILT SEATING SYSTEM, MODELS ARD-TSTORM, ARD-TP-320, ARD-TG424, ARD-TS525, ARD-TJAZZY, ARD-TLANCER
K992804 · Accelerated Rehab Designs, Inc. · Feb 2000