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510(k) K882264

BATTLE CREEK PILLOW by Battle Creek Equipment Co. — Product Code IQK

K882264 is an FDA 510(k) premarket notification submitted by Battle Creek Equipment Co. for the device "BATTLE CREEK PILLOW". The FDA issued a decision of Substantially Equivalent on August 9, 1988. The device falls under product code IQK (Orthosis, Cervical), a Class I device regulated under 21 CFR 890.3490. Battle Creek Equipment Co. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 1988
Date Received
May 31, 1988
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 by Battle Creek Equipment Co.

  • K863884 — PULSESTAR EXERCISE BIKE (October 23, 1986)
  • K854147 — BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL (December 27, 1985)
  • K854148 — BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL (December 17, 1985)
  • K851237 — THERMOPHORE ELECTRIC FOMENTATION UNIT (July 29, 1985)
  • K840280 — ROAD RUNNER ELECTRIC TREADMILL (February 4, 1984)
  • K791866 — STANDARD HEALTH BIKE MODEL 019 (October 4, 1979)

Other clearances for product code IQK

  • K930730 — DORMIE NECK SUPPORT SYSTEM (July 22, 1993)
  • K926291 — SCHUL-TEC IMMOBILIZER (March 30, 1993)
  • K895477 — NOVA PILLOW (January 10, 1990)
  • K896042 — MEDICAL DISPOSABLE BEDDING (January 10, 1990)
  • K850465 — CERVICAL COLLARS & HEAD HALTERS (April 25, 1985)
  • K832990 — STIFNICK IMMOBILIZING COLLAR (November 7, 1983)
  • K832001 — HEAD-IMMOBILIZER (July 12, 1983)
  • K831582 — VARI-SUPPORT NECK POSTURE PILLOW (June 15, 1983)
  • K830348 — VINYL EXTRICATION COLLAR (March 9, 1983)
  • K830351 — DISPOSABLE EXTRICATION COLLAR (March 9, 1983)

FDA data resources