Cleared Traditional

K973951 - LEVO COMPACT-EASY LCE

K973951 is an FDA 510(k) clearance for LEVO COMPACT-EASY LCE, 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 68-day FDA review.

K973951 · Levo USA · Physical Medicine device
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Dec 1997
Decision
68d
Days
Class 2
Risk

K973951 is an FDA 510(k) clearance for the LEVO COMPACT-EASY LCE. 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 68 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 - K973951

510(k) Number K973951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1997
Decision Date December 23, 1997
Days to Decision 68 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
47d faster than avg
Panel avg: 115d · This submission: 68d
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 17
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K973951.
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