Cleared Traditional

SAFE-STEP (K931517) - FDA 510(k) Clearance

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

K931517 · Lenjoy Engineering, Inc. · Physical Medicine device
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Mar 1995
Decision
714d
Days
Class 2
Risk

K931517 is an FDA 510(k) clearance for the SAFE-STEP. Classified as Device, Warning, Overload, External Limb, Powered (product code IRN), Class II - Special Controls.

Submitted by Lenjoy Engineering, Inc. (Hawthorne, US). The FDA issued a Cleared decision on March 10, 1995 after a review of 714 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5575 - 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: 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 Lenjoy Engineering, Inc. devices

Submission Details

510(k) Number K931517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 1993
Decision Date March 10, 1995
Days to Decision 714 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
599d slower than avg
Panel avg: 115d · This submission: 714d
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.