Cleared Traditional

ULE-2, MULE-2, HAND ACCESSORY KIT (K962855) - FDA 510(k) Clearance

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

K962855 · Penny and Giles Biometrics , Ltd. · Physical Medicine device
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Dec 1996
Decision
142d
Days
Class 2
Risk

K962855 is an FDA 510(k) clearance for the ULE-2, MULE-2, HAND ACCESSORY KIT. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Penny and Giles Biometrics , Ltd. (Gwent, Wales, GB). The FDA issued a Cleared decision on December 11, 1996 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5360 - 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 Penny and Giles Biometrics , Ltd. devices

Submission Details

510(k) Number K962855 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1996
Decision Date December 11, 1996
Days to Decision 142 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
27d slower than avg
Panel avg: 115d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ISD Exerciser, Measuring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5360
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.