Cleared Traditional

SPIFFY (K945650) - FDA 510(k) Clearance

Class I Physical Medicine device.

K945650 · Thames Valley Children'S Centre · Physical Medicine device
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Dec 1994
Decision
32d
Days
Class 1
Risk

K945650 is an FDA 510(k) clearance for the SPIFFY. Classified as Chair, Adjustable, Mechanical (product code INN), Class I - General Controls.

Submitted by Thames Valley Children'S Centre (London Ontario N6c 5y6, CA). The FDA issued a Cleared decision on December 19, 1994 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3100 - 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 Thames Valley Children'S Centre devices

Submission Details

510(k) Number K945650 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1994
Decision Date December 19, 1994
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code INN Chair, Adjustable, Mechanical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3100
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.