Cleared Traditional

K925122 - PACE SAVER LITTLE JR

K925122 is an FDA 510(k) clearance for PACE SAVER LITTLE JR, manufactured by Burke Mobility Products. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 537-day FDA review.

K925122 · Burke Mobility Products · Physical Medicine device
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Mar 1994
Decision
537d
Days
Class 2
Risk

K925122 is an FDA 510(k) clearance for the PACE SAVER LITTLE JR. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Burke Mobility Products (Mission, US). The FDA issued a Cleared decision on March 30, 1994 after a review of 537 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - 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 Burke Mobility Products devices

FDA 510(k) Submission Details - K925122

510(k) Number K925122 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received October 09, 1992
Decision Date March 30, 1994
Days to Decision 537 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
422d slower than avg
Panel avg: 115d · This submission: 537d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INI Device Classification - Class 2, Special Controls

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
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 - INI Vehicle, Motorized 3-wheeled

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