Cleared Traditional

EmpowerRide NAVIGATOR

K251886 · Empower Ride, LLC · Physical Medicine

Jan 2026

Decision

206d

Days

Class 1

Risk

About This 510(k) Submission

K251886 is an FDA 510(k) clearance for the EmpowerRide NAVIGATOR, a Wheelchair, Mechanical (Class I — General Controls, product code IOR), submitted by Empower Ride, LLC (Elkhorn, US). The FDA issued a Cleared decision on January 12, 2026, 206 days after receiving the submission on June 20, 2025. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3850.

Submission Details

510(k) Number	K251886 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 20, 2025
Decision Date	January 12, 2026
Days to Decision	206 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF

Device Classification

Product Code	IOR — Wheelchair, Mechanical
Device Class	Class I — General Controls
CFR Regulation	21 CFR 890.3850
Definition	A Mechanical Wheelchair Is A Manually 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/or Require An Assistive Device For Mobility.