Cleared Traditional

COMFORT STANDING WHEELCHAIR, HERO SERIES (K102734) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K102734 · Comfort Orthopedic Co., Ltd. · Physical Medicine device
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Dec 2010
Decision
83d
Days
Class 2
Risk

K102734 is an FDA 510(k) clearance for the COMFORT STANDING WHEELCHAIR, HERO SERIES. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Comfort Orthopedic Co., Ltd. (Columbus, US). The FDA issued a Cleared decision on December 14, 2010 after a review of 83 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 Comfort Orthopedic Co., Ltd. devices

Submission Details

510(k) Number K102734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2010
Decision Date December 14, 2010
Days to Decision 83 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
32d faster than avg
Panel avg: 115d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 65
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