Cleared Traditional

K031621 - HERO 1, MODEL LY-ESB220

K031621 is an FDA 510(k) clearance for HERO 1, manufactured by Comfort Orthopedic Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K031621 · Comfort Orthopedic Co., Ltd. · Physical Medicine device
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Jan 2004
Decision
244d
Days
Class 2
Risk

K031621 is an FDA 510(k) clearance for the HERO 1, MODEL LY-ESB220. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Comfort Orthopedic Co., Ltd. (Chia-Yi, TW). The FDA issued a Cleared decision on January 22, 2004 after a review of 244 days - an extended review 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: 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 - K031621

510(k) Number K031621 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2003
Decision Date January 22, 2004
Days to Decision 244 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
128d slower than avg
Panel avg: 116d · This submission: 244d
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 54
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K031621.
LEVO COMFORT II
K051387 · Levo AG · Jun 2005
LSA HELIUM
K042596 · Lifestand · Jan 2005
LSC LIFESTAND COMPACT
K041535 · Lifestand · Sep 2004
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
K031621 · HERO 1, MODEL LY-ESB220
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