Cleared Traditional

STANNAH POWER CHAIR, MODEL 201 (K994083) - FDA 510(k) Clearance

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

K994083 · Stannah Power Chairs , Ltd. · Physical Medicine device
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Apr 2001
Decision
488d
Days
Class 2
Risk

K994083 is an FDA 510(k) clearance for the STANNAH POWER CHAIR, MODEL 201. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Stannah Power Chairs , Ltd. (Andover, Hampshire, GB). The FDA issued a Cleared decision on April 4, 2001 after a review of 488 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Physical Medicine submissions.

View all Stannah Power Chairs , Ltd. devices

Submission Details

510(k) Number K994083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 03, 1999
Decision Date April 04, 2001
Days to Decision 488 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
373d slower than avg
Panel avg: 115d · This submission: 488d
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.

Regulatory Peers - IPL Wheelchair, Standup

All 65
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