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510(k) K935841

DR KOOL by Toronto Medical Corp. — Product Code ILO

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.

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  • K935808 — REVOLUTION LOWER LIMB CPM UNIT (March 18, 1994)
  • K925926 — MOBILIMB T1 TOE CPM UNIT (March 22, 1993)
  • K900795 — MOBILIMB L4 LOWER LIMB CPM UNIT (March 12, 1990)
  • K900466 — MOBILIMB W1 WRIST 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)

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  • 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)
  • K964354 — ARTOCOOL-S WATER CIRCULATING COLD PACK (August 29, 1997)
  • K964799 — ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY (August 29, 1997)