Cleared Traditional

MUSMATE WALKING AID (K073521) - FDA 510(k) Clearance

Class I Physical Medicine device.

K073521 · Musmate, Ltd. · Physical Medicine device
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Optimized for regulatory review, auditing and printing
Feb 2008
Decision
52d
Days
Class 1
Risk

K073521 is an FDA 510(k) clearance for the MUSMATE WALKING AID. Classified as Orthosis, Foot Drop (product code OHI), Class I - General Controls.

Submitted by Musmate, Ltd. (Bath, Somerset, GB). The FDA issued a Cleared decision on February 4, 2008 after a review of 52 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3475 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Musmate, Ltd. devices

Submission Details

510(k) Number K073521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 2007
Decision Date February 04, 2008
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OHI Orthosis, Foot Drop
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3475
Definition Aid For Drop Foot Or Similar Disorders Which Have A Lack Of Ankle Dorsiflexion. Indicated For Foot Raising Paresis.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.