Stifnick Immobilizing Collar

FDA 510(k) K832990 · Laerdal California, Inc.

Substantially Equivalent

510(k) numberK832990

Submission

Device name
Stifnick Immobilizing Collar
Applicant
Laerdal California, Inc.
Walker, MI, US
Received
September 1, 1983
Decision date
November 7, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IQK – Orthosis, Cervical
Device class
Class I (low risk)
Regulation
21 CFR 890.3490
Specialty
Physical Medicine

Other 510(k)s with product code IQK

510(k)DeviceApplicantDecision
K930730Dormie Neck Support SystemIQK · Traditional The Western Diagnostics Co.07/22/1993SE
K926291Schul-Tec ImmobilizerIQK · Traditional Medical Emergency Support Equipment03/30/1993SE
K896042Medical Disposable BeddingIQK · Traditional Keystone Veterinary Supplies, Inc.01/10/1990SE
K895477Nova PillowIQK · Traditional Nova Health Systems, Inc.01/10/1990SE
K882264Battle Creek PillowIQK · Traditional Battle Creek Equipment Co.08/09/1988SE
K850465Cervical Collars & Head HaltersIQK · Traditional Abco Dealers, Inc.04/25/1985SE
K832001Head-ImmobilizerIQK · Traditional Int'L Safety Corp.07/12/1983SE
K831582Vari-Support Neck Posture PillowIQK · Traditional Body Therapeutics, Inc.06/15/1983SE
K830351Disposable Extrication CollarIQK · Traditional Deip Enterprises, Inc.03/09/1983SE
K830350Cervical PillowIQK · Traditional Deip Enterprises, Inc.03/09/1983SE

More from Deip Enterprises, Inc.

510(k)DeviceDecision
K941578Statvac Portable Suction UnitBTA · Traditional 05/18/1994SE
K922842Stylet and Tracheal Lightwand (STL)BSR · Traditional 12/18/1992SE
K862875E-Vac(Tm)BTA · Traditional 11/03/1986SE
K843790Tracheal Tube Fixation DeviceCBH · Traditional 03/11/1985SE

Questions and answers

When was Stifnick Immobilizing Collar cleared by the FDA?

Stifnick Immobilizing Collar (K832990) received a 510(k) decision of Substantially Equivalent on November 7, 1983, 67 days after the submission was received.

What is the product code of K832990?

The FDA product code is IQK – Orthosis, Cervical, a Class I (low risk) device regulated under 21 CFR 890.3490.