Product Code: IQK FDA class 1 21 CFR 890.3490

Orthosis, Cervical

Physical Medicine

A cervical orthosis is an external collar or brace worn around the neck to provide support, restrict motion, and stabilize the cervical spine following injury, surgery, or in the management of degenerative conditions. It is classified as FDA Class 1, the lowest risk category, subject only to general controls. The product code is IQK, regulated under 21 CFR 890.3490, within the Physical Medicine medical specialty. This device is GMP exempt.

View on FDA

510(k)s

FEI Numbers

297

Registration Numbers

297

Unique Applicants

Years Active

Research product code IQK in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: IQK
Device Class: FDA class 1
Regulation Number: 890.3490
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 27 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K930730	DORMIE NECK SUPPORT SYSTEM	Jul 22, 1993	Substantially Equivalent	The Western Diagnostics Co.
K926291	SCHUL-TEC IMMOBILIZER	Mar 30, 1993	Substantially Equivalent	Medical Emergency Support Equipment
K896042	MEDICAL DISPOSABLE BEDDING	Jan 10, 1990	Substantially Equivalent	Keystone Veterinary Supplies, Inc.
K895477	NOVA PILLOW	Jan 10, 1990	Substantially Equivalent	Nova Health Systems, Inc.
K882264	BATTLE CREEK PILLOW	Aug 09, 1988	Substantially Equivalent	Battle Creek Equipment Co.
K850465	CERVICAL COLLARS & HEAD HALTERS	Apr 25, 1985	Substantially Equivalent	Abco Dealers, Inc.
K832990	STIFNICK IMMOBILIZING COLLAR	Nov 07, 1983	Substantially Equivalent	Laerdal California, Inc.
K832001	HEAD-IMMOBILIZER	Jul 12, 1983	Substantially Equivalent	Int'L Safety Corp.
K831582	VARI-SUPPORT NECK POSTURE PILLOW	Jun 15, 1983	Substantially Equivalent	Body Therapeutics, Inc.
K830351	DISPOSABLE EXTRICATION COLLAR	Mar 09, 1983	Substantially Equivalent	Deip Enterprises, Inc.
K830350	CERVICAL PILLOW	Mar 09, 1983	Substantially Equivalent	Deip Enterprises, Inc.
K830348	VINYL EXTRICATION COLLAR	Mar 09, 1983	Substantially Equivalent	Deip Enterprises, Inc.
K823667	CERVICAL COLLAR	Dec 30, 1982	Substantially Equivalent	Warm & Form, Orthopedic Materials
K823247	U-WAY QUICKOLLAR	Nov 16, 1982	Substantially Equivalent	Ems Industries, Inc.
K823161	CERVICAL COLLAR	Nov 10, 1982	Substantially Equivalent	Warm & Form, Orthopedic Materials
K821837	VARI-SUPPORT NECK POSTURE PILLOW	Jul 20, 1982	Substantially Equivalent	Body Therapeutics, Inc.
K820366	BECSIC COLLAR	Mar 01, 1982	Substantially Equivalent	Blackstone & Breglio Industries
K812019	LOXLEY EMERGENCY CERVICAL COLLAR	Oct 02, 1981	Substantially Equivalent	Loxley Medical
K811298	EXECUTIVE COLLAR	May 27, 1981	Substantially Equivalent	Orthomedics
K810024	BONNER BRACE	Jan 23, 1981	Substantially Equivalent	Bee Ent.
K803147	CONPHAR ADJUSTABLE CERVICAL COLLAR	Jan 08, 1981	Substantially Equivalent	Conphar, Inc.
K802442	LOW BACK POSTURE PILLOW	Oct 31, 1980	Substantially Equivalent	Body Therapeutics, Inc.
K801628	RESTRAINT, PROTECTIVE	Aug 07, 1980	Substantially Equivalent	The Owenby Co.
K800108	BASHAW CERVICAL IMMOBILIZER DEVICE	Feb 29, 1980	Substantially Equivalent	Bashaw Custom Specialties, Inc.
K780994	CERVICAL COLLAR	Jun 30, 1978	Substantially Equivalent	Fox Instruments, Inc.
K780136	COLLAR, CERVICAL, SPLIT	Jan 31, 1978	Substantially Equivalent	Richard'S Medical Equip., Inc.
K760644	NECKSAVER	Feb 16, 1977	Substantially Equivalent	Health Saver Corp.