Cleared Traditional

K971873 - LEVO ACTIVE-EASY LAE

K971873 is an FDA 510(k) clearance for LEVO ACTIVE-EASY LAE, manufactured by Levo USA. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K971873 · Levo USA · Physical Medicine device

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Jul 1997

Decision

44d

Days

Class 2

Risk

K971873 is an FDA 510(k) clearance for the LEVO ACTIVE-EASY LAE. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Levo USA (Dottikon, CH). The FDA issued a Cleared decision on July 3, 1997 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3900 - 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 - K971873

510(k) Number	K971873 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 20, 1997
Decision Date	July 03, 1997
Days to Decision	44 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

72d faster than avg

Panel avg: 116d · This submission: 44d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

IPL Device Classification - Class 2, Special Controls

Product Code	IPL Wheelchair, Standup
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 890.3900

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 - IPL Wheelchair, Standup

All 64

Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K971873.

THE LIBERATOR

K984391 · Liberator Wheelchairs, Inc. · Sep 1999

LEVO MOBIL LCM

K963817 · Levo USA · Dec 1997

LEVO COMPACT-EASY LCE

K973951 · Levo USA · Dec 1997

BOBCAT DX

K970543 · Quest Enabling Designs , Ltd. · Jun 1997

LEVO COMPACT LC

K963816 · Levo USA · Oct 1996

SUPERSTAND STAND-UP WHELLCHAIR

K962278 · The Standing Co., Inc. · Oct 1996

FDA 510(k) Resources - Physical Medicine

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K971873

Levo USA

Dottikon · CH

THOMAS RAEBER

Regulatory profile

4 submissions 4 cleared

100% clearance rate · Active in Physical Medicine

View all devices by Levo USA →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: July 3, 1997. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: September 2026.

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