Cleared Traditional

K895477 - NOVA PILLOW (FDA 510(k) Clearance)

Class I Physical Medicine device.

K895477 · Nova Health Systems, Inc. · Physical Medicine device
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Jan 1990
Decision
121d
Days
Class 1
Risk

K895477 is an FDA 510(k) clearance for the NOVA PILLOW. Classified as Orthosis, Cervical (product code IQK), Class I - General Controls.

Submitted by Nova Health Systems, Inc. (Blackwood, US). The FDA issued a Cleared decision on January 10, 1990 after a review of 121 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3490 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Nova Health Systems, Inc. devices

Submission Details

510(k) Number K895477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1989
Decision Date January 10, 1990
Days to Decision 121 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
6d slower than avg
Panel avg: 115d · This submission: 121d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IQK Orthosis, Cervical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 890.3490
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.