Cleared Traditional

K071761 - LLOYD LINDEN, MODEL E04

K071761 is an FDA 510(k) clearance for LLOYD LINDEN, manufactured by Lloyd Linden, Inc.. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K071761 · Lloyd Linden, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
35d
Days
Class 2
Risk

K071761 is an FDA 510(k) clearance for the LLOYD LINDEN, MODEL E04. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Lloyd Linden, Inc. (Banqiao, Taipei County, TW). The FDA issued a Cleared decision on August 3, 2007 after a review of 35 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 Lloyd Linden, Inc. devices

FDA 510(k) Submission Details - K071761

510(k) Number K071761 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 2007
Decision Date August 03, 2007
Days to Decision 35 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
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 20
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