Cleared Traditional

Element Pediatric Wheelchair (K182840) - FDA 510(k) Clearance

Class I Physical Medicine device.

K182840 · Leggero, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2019
Decision
202d
Days
Class 1
Risk

K182840 is an FDA 510(k) clearance for the Element Pediatric Wheelchair. Classified as Wheelchair, Mechanical (product code IOR), Class I - General Controls.

Submitted by Leggero, LLC (Burnet, US). The FDA issued a Cleared decision on April 29, 2019 after a review of 202 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3850 - 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 Leggero, LLC devices

Submission Details

510(k) Number K182840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2018
Decision Date April 29, 2019
Days to Decision 202 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
87d slower than avg
Panel avg: 115d · This submission: 202d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IOR Wheelchair, Mechanical
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Philosopher'S River, LLC
Mike Johnson

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IOR Wheelchair, Mechanical

All 456
Devices cleared under the same product code (IOR) and FDA review panel - the closest regulatory comparables to K182840.
Manual Wheelchair (LW01108)
K260642 · Anhui Longway Medical Technology Co., Ltd. · Jun 2026
Helio Kids
K260295 · Motion Composites · May 2026
Manual Wheelchair (DY01903(2))
K254141 · Guangdong Dayang Medical Technology Co., Ltd. · May 2026
Manual Wheelchair (7101L, 7102LHD)
K260121 · Foshan Nanhai Hongchen Medical Equipment Co., Ltd. · Apr 2026
Manual Wheelchair (W50)
K253632 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Jan 2026
EmpowerRide NAVIGATOR
K251886 · Empower Ride, LLC · Jan 2026