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510(k) K955326

SPORTS CONTRAST THERAPY SYSTEM ST 7000 by Burke Neutech, Inc. — Product Code ILO

K955326 is an FDA 510(k) premarket notification submitted by Burke Neutech, Inc. for the device "SPORTS CONTRAST THERAPY SYSTEM ST 7000". The FDA issued a decision of SN on April 10, 1996. 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
SN ()
Decision Date
April 10, 1996
Date Received
November 20, 1995
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.

  • 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)
  • K940160 — TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM (May 27, 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