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510(k) K070402

MODIFICATION TO POLAR CARE 500 by Breg, Inc. — Product Code ILO

K070402 is an FDA 510(k) premarket notification submitted by Breg, Inc. for the device "MODIFICATION TO POLAR CARE 500". The FDA issued a decision of Substantially Equivalent on March 29, 2007. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Breg, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2007
Date Received
February 12, 2007
Clearance Type
Special
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 Breg, Inc.

  • K183702 — Polar Care Wave (March 1, 2019)
  • K041714 — E-PAIN CARE (October 1, 2004)
  • K020988 — PAIN CARE 4200 (April 4, 2002)
  • K013928 — PAIN CARE 3200 (December 3, 2001)
  • K003611 — PAIN CARE MULTI-PORT CATHETER, MODEL 2000L (December 13, 2000)
  • K002073 — PAIN CARE 3000 (September 19, 2000)
  • K002321 — PAIN CARE 2000L (August 14, 2000)
  • K983454 — PAIN CARE 2000 (December 16, 1998)
  • K963596 — POLAR CARE 300 (December 4, 1996)
  • K961855 — POLAR CARE (MODEL 500/50000) (August 9, 1996)

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)
  • 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)
  • K964710 — BLEDSOE COLD CONTROL (May 9, 1997)

FDA data resources