Home / 510(k) Clearances / K760910

510(k) K760910

DISPOSABLE K-PADS by Gorman Rupp Industries — Product Code ILO

K760910 is an FDA 510(k) premarket notification submitted by Gorman Rupp Industries for the device "DISPOSABLE K-PADS". The FDA issued a decision of Substantially Equivalent on December 16, 1976. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Gorman Rupp Industries has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1976
Date Received
October 27, 1976
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 Gorman Rupp Industries

  • K771537 — AQUAMATIC K-MODULE MODEL K-20 (September 6, 1977)
  • K770839 — AQUAMATIC K-77 (June 8, 1977)
  • K770232 — BLOOD/FLUID WARMER MODEL DW-1000A (February 14, 1977)
  • K761337 — AQUAMATIC K-MODULE MODEL K-10 (January 10, 1977)
  • K761087 — ELECTRONIC CONTROL UNIT (December 6, 1976)

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