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510(k) K921711

FLEXION DISTRATION SUPPORT by Altoona Medical Supply — Product Code ILZ

K921711 is an FDA 510(k) premarket notification submitted by Altoona Medical Supply for the device "FLEXION DISTRATION SUPPORT". The FDA issued a decision of Substantially Equivalent on July 13, 1992. The device falls under product code ILZ (Accessories, Traction), a Class I device regulated under 21 CFR 890.5925. Altoona Medical Supply has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1992
Date Received
April 8, 1992
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 by Altoona Medical Supply

  • K913272 — EMS/400 (August 22, 1991)
  • K893874 — FUJITENS III (December 22, 1989)

Other clearances for product code ILZ

  • K895382 — VIBRA-TRAC TRACTION TABLE (October 16, 1989)
  • 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