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510(k) K925677

AUTOCHILL ACCESSORY KIT by Aircast, Inc. — Product Code ILO

K925677 is an FDA 510(k) premarket notification submitted by Aircast, Inc. for the device "AUTOCHILL ACCESSORY KIT". The FDA issued a decision of Substantially Equivalent on April 14, 1993. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Aircast, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 14, 1993
Date Received
July 16, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Water Circulating
Device Class
Class II
Regulation Number
890.5720
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)
  • K812094 — AIRCAST PNEUMATIC KNEE BRACE (August 13, 1981)
  • K810288 — AIRCAST TENNIS ARM BAND (February 12, 1981)
  • K780979 — AIRSTIRRUP PNEUMATIC ANKLE BRACE (June 30, 1978)

Other clearances for product code ILO

  • K213097 — Armory Motion (June 10, 2022)
  • K083008 — COOLSKIN (June 10, 2009)
  • K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP (May 8, 2008)
  • K072152 — JUNIPER CLN1 DERMAL COOLING DEVICE (September 7, 2007)
  • K070402 — MODIFICATION TO POLAR CARE 500 (March 29, 2007)
  • K040317 — IVC SYSTEM (May 7, 2004)
  • K973023 — INCARE HOT/ICE SYSTEM FOOT/ANKLE BLANKET (November 3, 1997)
  • K970197 — HTP-1500 LOCALIZED HEAT THERAPY PUMP (September 10, 1997)
  • K964799 — ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY (August 29, 1997)
  • K964354 — ARTOCOOL-S WATER CIRCULATING COLD PACK (August 29, 1997)

FDA data resources