Cleared Traditional

K051387 - LEVO COMFORT II

K051387 is an FDA 510(k) clearance for LEVO COMFORT II, 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 14-day FDA review.

K051387 · Levo AG · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2005
Decision
14d
Days
Class 2
Risk

K051387 is an FDA 510(k) clearance for the LEVO COMFORT II. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Levo AG (Wohlen, CH). The FDA issued a Cleared decision on June 10, 2005 after a review of 14 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 - K051387

510(k) Number K051387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2005
Decision Date June 10, 2005
Days to Decision 14 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
102d faster than avg
Panel avg: 116d · This submission: 14d
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 K051387.
LSC, MODEL 3
K061726 · Lifestand · Dec 2006
PARAGOLFER
K060936 · Parabasetec, GmbH · Aug 2006
ALILIFE STAND UP POWERED WHEELCHAIR, HC-300
K052375 · Alilife Technological Co., Ltd. · Sep 2005
LSA HELIUM
K042596 · Lifestand · Jan 2005
LSC LIFESTAND COMPACT
K041535 · Lifestand · Sep 2004
HERO 1, MODEL LY-ESB220
K031621 · Comfort Orthopedic Co., Ltd. · Jan 2004

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.