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510(k) K895382

VIBRA-TRAC TRACTION TABLE by Vibra-Trac Industries — Product Code ILZ

K895382 is an FDA 510(k) premarket notification submitted by Vibra-Trac Industries for the device "VIBRA-TRAC TRACTION TABLE". The FDA issued a decision of Substantially Equivalent on October 16, 1989. The device falls under product code ILZ (Accessories, Traction), a Class I device regulated under 21 CFR 890.5925.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1989
Date Received
August 30, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Traction
Device Class
Class I
Regulation Number
890.5925
Review Panel
PM
Submission Type

Other clearances for product code ILZ

  • K921711 — FLEXION DISTRATION SUPPORT (July 13, 1992)
  • K884340 — AMX-110, AMX-II AND AMX-III (January 24, 1989)
  • K852398 — VECTOR BAR SUSPENSION/TRACTION UNIT (August 12, 1985)
  • K844490 — TRACTION ACCESSORIES (February 21, 1985)
  • K831135 — SAUNDERS #7080 CERVICAL TRACTION SYS (June 24, 1983)
  • K830245 — HEAD HALTER (March 9, 1983)
  • K823659 — PELVIC TRACTION BELT (December 30, 1982)
  • K823166 — PELVIC TRACTION BELT (November 10, 1982)
  • K820663 — BOGER AUTO-TRACTION DEVICE (May 3, 1982)
  • K791808 — CERVI-TRAC (October 1, 1979)

FDA data resources