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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 116d · 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 596
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K001923.
C.T.M. POWER CHAIR, MODEL HS-5600
K002983 · Warepalmy Enterprise, LLC (Usa) · Oct 2000
JET 1 POWERED WHEELCHAIR
K001970 · Pride Mobility Products Corp. · Sep 2000
RAEBBITT/EVOLUTION POWERED WHEELCHAIR
K000678 · Otto Bock Orthopedic Industry, Inc. · Sep 2000
RANGER II M6, MODEL IN-888WNL
K002157 · Invacare Corp. · Aug 2000
MAGIC MOBILITY 4 X 4 WHEELCHAIR
K000796 · Vestil Manufacturing Corp. · Aug 2000
WIN-1 TANGO
K000204 · Duracare Medical Equipment, L.C. · Aug 2000
K001923 · REGENCY POWER WHEELCHAIR, MODEL 7200, 7500 & 7800
Download PDF FDA Summary Gendron, Inc.