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510(k) K935841

DR KOOL by Toronto Medical Corp. — Product Code ILO

K935841 is an FDA 510(k) premarket notification submitted by Toronto Medical Corp. for the device "DR KOOL". The FDA issued a decision of SN on August 29, 1994. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Toronto Medical Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
August 29, 1994
Date Received
December 7, 1993
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 Toronto Medical Corp.

  • K950682 — W2 WRIST CPM UNIT (September 13, 1995)
  • K945121 — A3 ANKLE CPM UNIT (February 17, 1995)
  • K935587 — MULTILINK SHOULDER CPM UNIT (December 14, 1994)
  • K935808 — REVOLUTION LOWER LIMB CPM UNIT (March 18, 1994)
  • K925926 — MOBILIMB T1 TOE CPM UNIT (March 22, 1993)
  • K900466 — MOBILIMB W1 WRIST CPM UNIT (March 12, 1990)
  • K900795 — MOBILIMB L4 LOWER LIMB CPM UNIT (March 12, 1990)
  • K900794 — MOBILIMB H3 HAND CPM UNIT (March 2, 1990)
  • K895720 — MOBILIMB J1 TMJ CPM UNIT (January 4, 1990)
  • K891345 — MOBILIMB CPM SHOULDER UNIT (April 24, 1989)

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