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510(k) K832001

HEAD-IMMOBILIZER by Int'L Safety Corp. — Product Code IQK

K832001 is an FDA 510(k) premarket notification submitted by Int'L Safety Corp. for the device "HEAD-IMMOBILIZER". The FDA issued a decision of Substantially Equivalent on July 12, 1983. The device falls under product code IQK (Orthosis, Cervical), a Class I device regulated under 21 CFR 890.3490.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1983
Date Received
June 22, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Cervical
Device Class
Class I
Regulation Number
890.3490
Review Panel
PM
Submission Type

Other clearances for product code IQK

  • K930730 — DORMIE NECK SUPPORT SYSTEM (July 22, 1993)
  • K926291 — SCHUL-TEC IMMOBILIZER (March 30, 1993)
  • K896042 — MEDICAL DISPOSABLE BEDDING (January 10, 1990)
  • K895477 — NOVA PILLOW (January 10, 1990)
  • K882264 — BATTLE CREEK PILLOW (August 9, 1988)
  • K850465 — CERVICAL COLLARS & HEAD HALTERS (April 25, 1985)
  • K832990 — STIFNICK IMMOBILIZING COLLAR (November 7, 1983)
  • K831582 — VARI-SUPPORT NECK POSTURE PILLOW (June 15, 1983)
  • K830350 — CERVICAL PILLOW (March 9, 1983)
  • K830348 — VINYL EXTRICATION COLLAR (March 9, 1983)

FDA data resources