Cleared Traditional

K895477 - NOVA PILLOW

K895477 is an FDA 510(k) clearance for NOVA PILLOW, manufactured by Nova Health Systems, Inc.. The device is a Class 1 Physical Medicine device with product code IQK cleared through the Traditional 510(k) pathway after a 121-day FDA review.

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

FDA 510(k) Submission Details - K895477

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.

IQK Device Classification - Class 1, General Controls

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.

Regulatory Peers - IQK Orthosis, Cervical

Devices cleared under the same product code (IQK) and FDA review panel - the closest regulatory comparables to K895477.
CERVICAL COLLARS & HEAD HALTERS
K850465 · Abco Dealers, Inc. · Apr 1985
CERVICAL COLLAR
K823667 · Warm & Form, Orthopedic Materials · Dec 1982
CERVICAL COLLAR
K823161 · Warm & Form, Orthopedic Materials · Nov 1982
CONPHAR ADJUSTABLE CERVICAL COLLAR
K803147 · Conphar, Inc. · Jan 1981
COLLAR, CERVICAL, SPLIT
K780136 · Richard'S Medical Equip., Inc. · Jan 1978