Cleared Traditional

K963817 - LEVO MOBIL LCM

K963817 is an FDA 510(k) clearance for LEVO MOBIL LCM, 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 456-day FDA review.

K963817 · Levo USA · Physical Medicine device
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Dec 1997
Decision
456d
Days
Class 2
Risk

K963817 is an FDA 510(k) clearance for the LEVO MOBIL LCM. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Levo USA (Dottikon, CH). The FDA issued a Cleared decision on December 23, 1997 after a review of 456 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

FDA 510(k) Submission Details - K963817

510(k) Number K963817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1996
Decision Date December 23, 1997
Days to Decision 456 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
340d slower than avg
Panel avg: 116d · This submission: 456d
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 K963817.
NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR
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K994083 · Stannah Power Chairs , Ltd. · Apr 2001
THE LIBERATOR
K984391 · Liberator Wheelchairs, Inc. · Sep 1999
LEVO COMPACT-EASY LCE
K973951 · Levo USA · Dec 1997
LEVO ACTIVE-EASY LAE
K971873 · Levo USA · Jul 1997
BOBCAT DX
K970543 · Quest Enabling Designs , Ltd. · Jun 1997
K963817 · LEVO MOBIL LCM
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