Cleared Traditional

K850875 - ACTION-WHEELS & PLAY WHEELS (FDA 510(k) Clearance)

K850875 · Ketronic, Inc. · Physical Medicine device
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May 1985
Decision
76d
Days
-
Risk

K850875 is an FDA 510(k) clearance for the ACTION-WHEELS & PLAY WHEELS.

Submitted by Ketronic, Inc. (The Netherlands, NL). The FDA issued a Cleared decision on May 16, 1985 after a review of 76 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 Ketronic, Inc. devices

Submission Details

510(k) Number K850875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1985
Decision Date May 16, 1985
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -