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510(k) K940160

TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM by Burke Neutech, Inc. — Product Code ILO

K940160 is an FDA 510(k) premarket notification submitted by Burke Neutech, Inc. for the device "TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on May 27, 1994. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Burke Neutech, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1994
Date Received
January 12, 1994
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 Burke Neutech, Inc.

  • K955326 — SPORTS CONTRAST THERAPY SYSTEM ST 7000 (April 10, 1996)
  • K952117 — EPILATOR (October 19, 1995)
  • K943497 — CONTRAST 7000 THERAPY SYSTEM (June 7, 1995)
  • K945803 — THERMAFLEX, MODEL SD 55 C.P.M.H. (May 11, 1995)
  • K942926 — NEURO-AIDE (August 3, 1994)
  • K926151 — LSI6000 THERMAL THERAPY SYSTEM (May 26, 1993)

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