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.

View all Comfort Orthopedic Co., Ltd. devices

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
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 115d · 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.

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All 18
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