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510(k) K780979

AIRSTIRRUP PNEUMATIC ANKLE BRACE by Aircast, Inc. — Product Code IQI

K780979 is an FDA 510(k) premarket notification submitted by Aircast, Inc. for the device "AIRSTIRRUP PNEUMATIC ANKLE BRACE". The FDA issued a decision of Substantially Equivalent on June 30, 1978. The device falls under product code IQI (Orthosis, Limb Brace), a Class I device regulated under 21 CFR 890.3475. Aircast, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1978
Date Received
June 9, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Orthosis, Limb Brace
Device Class
Class I
Regulation Number
890.3475
Review Panel
PM
Submission Type

Other clearances by Aircast, Inc.

  • K024019 — ARTERIALFLOW SYSTEM, MODEL 32A (June 3, 2003)
  • K023800 — VENAFLOW REUSABLE CALF AIRCELL, MODEL 3018, VENAFLOW DISPOSABLE CALF COVER, MODE (February 10, 2003)
  • K992454 — VENAFLOW SYSTEM, MODEL 30A (January 13, 2000)
  • K964238 — AIRCAST VENA FLOW STERILE DISPOSABLE CUFFS (September 8, 1997)
  • K961676 — AIRCAST VENAFLOW SYSTEM (MODIFICATION) (March 28, 1997)
  • K933977 — AIRCAST EDEMAFLOW SYSTEM (December 7, 1993)
  • K932900 — AIRCAST VENAFLOW SYSTEM (October 25, 1993)
  • K925677 — AUTOCHILL ACCESSORY KIT (April 14, 1993)
  • K812094 — AIRCAST PNEUMATIC KNEE BRACE (August 13, 1981)
  • K810288 — AIRCAST TENNIS ARM BAND (February 12, 1981)

Other clearances for product code IQI

  • K143458 — Neurosplint (August 13, 2015)
  • K052771 — SENSOR WALK (May 3, 2006)
  • K031576 — SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 (July 31, 2003)
  • K926391 — ACCUFLEX DYNAMIC ELBOW ORTHOSIS (July 22, 1993)
  • K910974 — MCCONNELL SHOULDER BRACE (March 21, 1991)
  • K874502 — GAIT-AID ORTHOPEDIC INSOLE (November 30, 1987)
  • K831542 — ADJUSTABLE POLYCENTRIC ELBOW HINGE (June 24, 1983)
  • K831615 — DROP FOOT BRACE (June 15, 1983)
  • K823812 — VARIOUS SUPPORTS AND SPLINTS (January 14, 1983)
  • K823113 — BRACE-UP ALL PURPOSE WRIST BAND (November 16, 1982)

FDA data resources