Home / 510(k) Clearances / K943497

510(k) K943497

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

K943497 is an FDA 510(k) premarket notification submitted by Burke Neutech, Inc. for the device "CONTRAST 7000 THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on June 7, 1995. 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
June 7, 1995
Date Received
July 19, 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)
  • 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)
  • K964354 — ARTOCOOL-S WATER CIRCULATING COLD PACK (August 29, 1997)
  • K964799 — ARTROTHERM CRYOTHERAPY AND THERNOTHERAPY (August 29, 1997)

FDA data resources