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510(k) K832819

MUL-T-PAD by Gaymar Industries, Inc. — Product Code ILO

K832819 is an FDA 510(k) premarket notification submitted by Gaymar Industries, Inc. for the device "MUL-T-PAD". The FDA issued a decision of Substantially Equivalent on September 26, 1983. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Gaymar Industries, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1983
Date Received
August 19, 1983
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 Gaymar Industries, Inc.

  • K100585 — MEDI-THERM HYPER/HYPOTHERMIA SYSTEM, MODELS MTA6900, MTA7900 (January 20, 2011)
  • K073675 — T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP (May 8, 2008)
  • K962788 — CLINIDYNE ROTATIONAL THERAPY MATTRESS SYSTEM (April 30, 1997)
  • K963067 — SOF. PRESS EPC 51 SYSTEM (January 28, 1997)
  • K961854 — SPR PLUS II OVERLAY SYSTEM (CL250/CL212 (August 9, 1996)
  • K942881 — TC 3000 (May 23, 1995)
  • K930345 — TC2000 POWER UNIT AND ACCESSORIES (August 6, 1993)
  • K914921 — SCM-3 AND ACCESSORIES (March 12, 1992)
  • K914805 — TC-1000, TC-1050 SYSTEM (January 7, 1992)
  • K914851 — CLA-1400 SYSTEM (November 13, 1991)

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