Cleared Traditional

K030893 - LEVO COMBI

K030893 is an FDA 510(k) clearance for LEVO COMBI, 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 12-day FDA review.

K030893 · Levo AG · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2003
Decision
12d
Days
Class 2
Risk

K030893 is an FDA 510(k) clearance for the LEVO COMBI. 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 April 2, 2003 after a review of 12 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 - K030893

510(k) Number K030893 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2003
Decision Date April 02, 2003
Days to Decision 12 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
104d faster than avg
Panel avg: 116d · This submission: 12d
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 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 K030893.
POWERSTAND STAND-UP WHEELCHAIR
K032101 · The Standing Co., Inc. · Jan 2004
COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2
K031618 · Comfort Orthopedic Co., Ltd. · Dec 2003
RABBIT MOBILE STANDING FRAME
K030882 · R82 A/S · Apr 2003
NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES
K021165 · Bromac Assistive Technology · Jul 2002
VERTRAN STANDING WHEELCHAIR
K011530 · Fena Design, Inc. · Oct 2001
NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR
K012345 · Bromac Assistive Technology · Oct 2001

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.