Cleared Traditional

K042596 - LSA HELIUM

K042596 is an FDA 510(k) clearance for LSA HELIUM, manufactured by Lifestand. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K042596 · Lifestand · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
125d
Days
Class 2
Risk

K042596 is an FDA 510(k) clearance for the LSA HELIUM. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Lifestand (Houston, US). The FDA issued a Cleared decision on January 26, 2005 after a review of 125 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K042596

510(k) Number K042596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2004
Decision Date January 26, 2005
Days to Decision 125 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 116d · This submission: 125d
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 64
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K042596.
PARAGOLFER
K060936 · Parabasetec, GmbH · Aug 2006
ALILIFE STAND UP POWERED WHEELCHAIR, HC-300
K052375 · Alilife Technological Co., Ltd. · Sep 2005
LEVO COMFORT II
K051387 · Levo AG · Jun 2005
LSC LIFESTAND COMPACT
K041535 · Lifestand · Sep 2004
HERO 1, MODEL LY-ESB220
K031621 · Comfort Orthopedic Co., Ltd. · Jan 2004
POWERSTAND STAND-UP WHEELCHAIR
K032101 · The Standing Co., Inc. · Jan 2004
K042596 · LSA HELIUM
Download PDF FDA Summary Lifestand