Cleared Traditional

K926499 - SHUTTLE SC-140

K926499 is an FDA 510(k) clearance for SHUTTLE SC-140, manufactured by Pride Health Care, Inc.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Traditional 510(k) pathway after a 454-day FDA review.

K926499 · Pride Health Care, Inc. · Physical Medicine device
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Mar 1994
Decision
454d
Days
Class 2
Risk

K926499 is an FDA 510(k) clearance for the SHUTTLE SC-140. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Pride Health Care, Inc. (Pittston, US). The FDA issued a Cleared decision on March 28, 1994 after a review of 454 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 Pride Health Care, Inc. devices

FDA 510(k) Submission Details - K926499

510(k) Number K926499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1992
Decision Date March 28, 1994
Days to Decision 454 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
339d slower than avg
Panel avg: 115d · This submission: 454d
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

All 232
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