Cleared Traditional

K851261 - ALEXIS

K851261 is an FDA 510(k) clearance for ALEXIS, manufactured by Intex Research & Development Center. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K851261 · Intex Research & Development Center · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1985
Decision
95d
Days
Class 2
Risk

K851261 is an FDA 510(k) clearance for the ALEXIS. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Intex Research & Development Center (Palo Alto, US). The FDA issued a Cleared decision on July 1, 1985 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Intex Research & Development Center devices

FDA 510(k) Submission Details - K851261

510(k) Number K851261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1985
Decision Date July 01, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 115d · This submission: 95d
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 407
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K851261.
RANGER-X
K852811 · Invacare Corp. · Aug 1985
RANGER(II)
K852813 · Invacare Corp. · Aug 1985
POWER DRIVE WHEELCHAIR-VARIOUS
K851381 · Everest & Jennings, Inc. · Jul 1985
OMNIDIRECTIONAL POWERED WHEEL CHAIR
K841542 · Kinetic Concepts, Inc. · May 1984
POSITELEC WHEELCHAIR
K840640 · Poirier S.A. · Feb 1984
PREMIER
K834552 · Everest & Jennings, Inc. · Jan 1984