Cleared Traditional

A-BEC 18 (K865002) - FDA 510(k) Clearance

K865002 · A-Bec Mobility, Inc. · Physical Medicine device
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Feb 1987
Decision
46d
Days
-
Risk

K865002 is an FDA 510(k) clearance for the A-BEC 18.

Submitted by A-Bec Mobility, Inc. (Torrance, US). The FDA issued a Cleared decision on February 6, 1987 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel. 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 A-Bec Mobility, Inc. devices

Submission Details

510(k) Number K865002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1986
Decision Date February 06, 1987
Days to Decision 46 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 115d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -