Cleared Traditional

K832001 - HEAD-IMMOBILIZER

K832001 is an FDA 510(k) clearance for HEAD-IMMOBILIZER, manufactured by Int'L Safety Corp.. The device is a Class 1 Physical Medicine device with product code IQK cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K832001 · Int'L Safety Corp. · Physical Medicine device
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Jul 1983
Decision
20d
Days
Class 1
Risk

K832001 is an FDA 510(k) clearance for the HEAD-IMMOBILIZER. Classified as Orthosis, Cervical (product code IQK), Class I - General Controls.

Submitted by Int'L Safety Corp. (Mchenry, US). The FDA issued a Cleared decision on July 12, 1983 after a review of 20 days - a notably fast clearance cycle.

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: 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 Int'L Safety Corp. devices

FDA 510(k) Submission Details - K832001

510(k) Number K832001 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1983
Decision Date July 12, 1983
Days to Decision 20 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
95d faster than avg
Panel avg: 115d · This submission: 20d
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 K832001.
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