Cleared Traditional

K962528 - OLYMPUS MOBILE CHAIR/COUCH (FDA 510(k) Clearance)

Class I Radiology device.

K962528 · Keymed (Medical & Industrial Equipment), Ltd. · Radiology device
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Dec 1996
Decision
168d
Days
Class 1
Risk

K962528 is an FDA 510(k) clearance for the OLYMPUS MOBILE CHAIR/COUCH. Classified as Chair, Surgical, Non-electrical (product code FZK), Class I - General Controls.

Submitted by Keymed (Medical & Industrial Equipment), Ltd. (Southend-On-Sea, Essex, GB). The FDA issued a Cleared decision on December 12, 1996 after a review of 168 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 878.4950 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Keymed (Medical & Industrial Equipment), Ltd. devices

Submission Details

510(k) Number K962528 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1996
Decision Date December 12, 1996
Days to Decision 168 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 107d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FZK Chair, Surgical, Non-electrical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4950
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.