Cleared Traditional

K083017 - LEVO C3

K083017 is an FDA 510(k) clearance for LEVO C3, manufactured by Levo AG. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K083017 · Levo AG · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
15d
Days
Class 2
Risk

K083017 is an FDA 510(k) clearance for the LEVO C3. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Levo AG (5610 Wohlen, CH). The FDA issued a Cleared decision on October 24, 2008 after a review of 15 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 - K083017

510(k) Number K083017 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 2008
Decision Date October 24, 2008
Days to Decision 15 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 116d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Sud America, Inc.
STEFAN PREISS

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 - IPL Wheelchair, Standup

All 49
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K083017.
HIROLLER ELEVATING WHEELCHAIR
K102837 · Max Mobility, LLC · Dec 2010
COMFORT STANDING WHEELCHAIR, HERO SERIES
K102734 · Comfort Orthopedic Co., Ltd. · Dec 2010
POWER STANDING DANI
K090256 · Davismade, Inc. · Jul 2009
BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)
K072475 · Etac Sverige AB · Dec 2007
LLOYD LINDEN, MODEL E04
K071761 · Lloyd Linden, Inc. · Aug 2007
WHEELCHAIR MODEL STS
K071390 · Innovative Products, Inc. · Jul 2007

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.