Cleared Traditional

HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P (K102236) - FDA 510(k) Clearance

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

K102236 · D.T. Davis Enterprises Ltd. T/A Hovertech Int'L · Physical Medicine device
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Nov 2010
Decision
101d
Days
Class 2
Risk

K102236 is an FDA 510(k) clearance for the HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P. Classified as Stretcher, Wheeled, Powered (product code INK), Class II - Special Controls.

Submitted by D.T. Davis Enterprises Ltd. T/A Hovertech Int'L (Bethlehem, US). The FDA issued a Cleared decision on November 18, 2010 after a review of 101 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3690 - 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 D.T. Davis Enterprises Ltd. T/A Hovertech Int'L devices

Submission Details

510(k) Number K102236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 2010
Decision Date November 18, 2010
Days to Decision 101 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
14d faster than avg
Panel avg: 115d · This submission: 101d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code INK Stretcher, Wheeled, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3690
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.