Cleared Traditional

K963816 - LEVO COMPACT LC

K963816 is an FDA 510(k) clearance for LEVO COMPACT LC, 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 37-day FDA review.

K963816 · Levo USA · Physical Medicine device
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Oct 1996
Decision
37d
Days
Class 2
Risk

K963816 is an FDA 510(k) clearance for the LEVO COMPACT LC. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Levo USA (Dottikon, CH). The FDA issued a Cleared decision on October 30, 1996 after a review of 37 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.

View all Levo USA devices

FDA 510(k) Submission Details - K963816

510(k) Number K963816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1996
Decision Date October 30, 1996
Days to Decision 37 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 115d · This submission: 37d
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 18
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K963816.
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
CHIEF STANDUP WHEELCHAIR
K940852 · Redman, Inc. · Feb 1995
CHIEF SR
K940919 · Redman, Inc. · Feb 1995
VERTICALIBRE WHEELCHAIR
K840626 · Poirier S.A. · Feb 1984