Home / 510(k) Clearances / K962983

510(k) K962983

STERILE SOFT-TEMP by Adroit Medical Systems, Inc. — Product Code ILO

K962983 is an FDA 510(k) premarket notification submitted by Adroit Medical Systems, Inc. for the device "STERILE SOFT-TEMP". The FDA issued a decision of Substantially Equivalent on January 10, 1997. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Adroit Medical Systems, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 10, 1997
Date Received
August 1, 1996
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 Adroit Medical Systems, Inc.

  • K073712 — SOFT AIR, MODEL SA 4000 AND MISTRAL AIR, MODEL MA0100 (June 6, 2008)
  • K973981 — SAFEPASS STERILIZATION POUCH (January 29, 1998)
  • K970197 — HTP-1500 LOCALIZED HEAT THERAPY PUMP (September 10, 1997)
  • K921920 — SOFT-TEMP (December 11, 1992)
  • K921928 — SOFT-COVER (November 6, 1992)

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