Cleared Traditional

K934238 - MULE

K934238 is an FDA 510(k) clearance for MULE, manufactured by Penny and Giles Biometrics , Ltd.. The device is a Class 2 Physical Medicine device with product code ISD cleared through the Traditional 510(k) pathway after a 422-day FDA review.

K934238 · Penny and Giles Biometrics , Ltd. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
422d
Days
Class 2
Risk

K934238 is an FDA 510(k) clearance for the MULE. Classified as Exerciser, Measuring (product code ISD), Class II - Special Controls.

Submitted by Penny and Giles Biometrics , Ltd. (England, GB). The FDA issued a Cleared decision on October 26, 1994 after a review of 422 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K934238

510(k) Number K934238 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1993
Decision Date October 26, 1994
Days to Decision 422 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
307d slower than avg
Panel avg: 115d · This submission: 422d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ISD Device Classification - Class 2, Special Controls

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.

Regulatory Peers - ISD Exerciser, Measuring

All 26
Devices cleared under the same product code (ISD) and FDA review panel - the closest regulatory comparables to K934238.
REHCOR
K990813 · Electromed Corp. · Apr 1999
ULE-2, MULE-2, HAND ACCESSORY KIT
K962855 · Penny and Giles Biometrics , Ltd. · Dec 1996
DAVID BACK CLINIC SYSTEM
K952163 · Kinetic Resources, Inc. · Aug 1996
STAIR CLIMBER
K926278 · Henley Intl. · May 1994
UPPER BODY EXERCISER
K926279 · Henley Intl. · May 1994
EXERCISE BICYCLE
K926287 · Henley Intl. · Mar 1994