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510(k) K832193

NICE PACK by Universal Medical Instrument Corp. — Product Code IME

K832193 is an FDA 510(k) premarket notification submitted by Universal Medical Instrument Corp. for the device "NICE PACK". The FDA issued a decision of Substantially Equivalent on August 31, 1983. The device falls under product code IME (Pack, Hot Or Cold, Reusable), a Class I device regulated under 21 CFR 890.5700. Universal Medical Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1983
Date Received
July 8, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Reusable
Device Class
Class I
Regulation Number
890.5700
Review Panel
PM
Submission Type

Other clearances by Universal Medical Instrument Corp.

  • K962180 — CATH SEAL (November 7, 1996)
  • K935077 — CATH-SEAL (June 7, 1994)
  • K897128 — UMI BRAIDED CATHETER CONNECTOR (March 1, 1990)
  • K881796 — UMI DISPOSABLE BUTTERFLY STYLE PUNCTURE NEEDLE (July 26, 1988)
  • K863178 — UMI STEERABLE TORQUE GUIDE WIRE (September 19, 1986)
  • K861984 — UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO (August 5, 1986)
  • K860168 — UMI (FRANSEEN,WESTCOTT,GREENE,MENGHINI)BIO. NEEDLE (February 19, 1986)
  • K851088 — UMI ANGIOGRAPHIC CATHETER (May 16, 1985)
  • K850820 — PERCUTANEOUS CATHETER INTRODUCER W/CATH-SEAL & SID (April 10, 1985)
  • K844558 — UMI AMNIOCENTESIS KIT W/SPINAL NEEDLE (January 31, 1985)

Other clearances for product code IME

  • K923627 — COLD PACK (April 14, 1993)
  • K915876 — HOTPAD (February 12, 1993)
  • K921446 — HOT OR COLD PACK (THERMIPAQ) (July 13, 1992)
  • K905207 — MICRO-AIRE SOFT-ICE, COLD THERAPY COMPRESS (January 22, 1991)
  • K882413 — SUBOCCIPITAL ICE PILLOW (November 30, 1988)
  • K863654 — RE-HEATER, HOT PACK (October 23, 1986)
  • K831899 — ENSWELL (July 7, 1983)
  • K830981 — MICROPAK MOIST HEAT PAD (June 3, 1983)
  • K830416 — ICY COLD ICE CAP (March 10, 1983)
  • K823649 — THERMOELASTOMER HOT/COLD COMPRESS BK7186 (January 21, 1983)

FDA data resources