Cleared Traditional

ACCUTRED SHOE (K991313) - FDA 510(k) Clearance

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

K991313 · Orthopedic Technology Research, Inc. · Physical Medicine device
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Jun 1999
Decision
68d
Days
Class 2
Risk

K991313 is an FDA 510(k) clearance for the ACCUTRED SHOE. Classified as Device, Warning, Overload, External Limb, Powered (product code IRN), Class II - Special Controls.

Submitted by Orthopedic Technology Research, Inc. (Hixson, US). The FDA issued a Cleared decision on June 23, 1999 after a review of 68 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5575 - 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 Orthopedic Technology Research, Inc. devices

Submission Details

510(k) Number K991313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1999
Decision Date June 23, 1999
Days to Decision 68 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 115d · This submission: 68d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IRN Device, Warning, Overload, External Limb, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5575
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.