Home / 510(k) Clearances / K940858

510(k) K940858

THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS) by Innovation Sports, Inc. — Product Code ILO

K940858 is an FDA 510(k) premarket notification submitted by Innovation Sports, Inc. for the device "THERA COOL HOME UNIT/COOLPAC(AMBU/RESERVIOR UNITS)". The FDA issued a decision of SN on July 12, 1994. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Innovation Sports, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SN ()
Decision Date
July 12, 1994
Date Received
February 23, 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 Innovation Sports, Inc.

  • K831310 — BRACE C.T. (May 16, 1983)

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