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510(k) K812094

AIRCAST PNEUMATIC KNEE BRACE by Aircast, Inc. — Product Code ITQ

K812094 is an FDA 510(k) premarket notification submitted by Aircast, Inc. for the device "AIRCAST PNEUMATIC KNEE BRACE". The FDA issued a decision of Substantially Equivalent on August 13, 1981. The device falls under product code ITQ (Joint, Knee, External 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
August 13, 1981
Date Received
July 24, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Joint, Knee, External 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)
  • K810288 — AIRCAST TENNIS ARM BAND (February 12, 1981)
  • K780979 — AIRSTIRRUP PNEUMATIC ANKLE BRACE (June 30, 1978)

Other clearances for product code ITQ

  • K831044 — LIMITED MOTION FUNCTIONAL KNEE BRACE (June 24, 1983)
  • K831310 — BRACE C.T. (May 16, 1983)
  • K823658 — DELUXE KNEE IMMOBILIZER(UNIVERSAL) (December 30, 1982)
  • K823397 — ANATOMIC FRACTURE BRACE (November 29, 1982)
  • K823159 — DELUXE KNEE IMMOBILIZER (November 10, 1982)
  • K812423 — NEOPRENE KNEE SUPPORT (September 14, 1981)
  • K811689 — CYLINDER KNEE CAST/SPLINT (June 25, 1981)
  • K810222 — LIMB ORHTOSIS (February 4, 1981)
  • K802673 — KNEE BRACE/STABILIZER (November 12, 1980)
  • K780892 — FRACTURE BRACING (June 13, 1978)

FDA data resources