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510(k) K954877

OMNI COLD GEL PACKS by Omni Therm, Inc. — Product Code IMD

K954877 is an FDA 510(k) premarket notification submitted by Omni Therm, Inc. for the device "OMNI COLD GEL PACKS". The FDA issued a decision of SN on February 13, 1996. The device falls under product code IMD (Pack, Hot Or Cold, Disposable), a Class I device regulated under 21 CFR 890.5710. Omni Therm, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
February 13, 1996
Date Received
October 24, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Hot Or Cold, Disposable
Device Class
Class I
Regulation Number
890.5710
Review Panel
PM
Submission Type

Other clearances by Omni Therm, Inc.

  • K955788 — IMNI HOT PACKS (September 4, 1996)
  • K961176 — OMNI COLD GEL PACKS (September 4, 1996)
  • K936084 — OMNI WARM GEL PACKS (March 31, 1994)
  • K864853 — OMNI THERM TEMPERATURE MONITOR (February 4, 1987)

Other clearances for product code IMD

  • K221653 — InfaTherm Disposable Infant Warming Mattress (October 6, 2022)
  • K163295 — Infant Transport Mattress Warmer with Disc (July 24, 2017)
  • K112547 — NEO NEST (March 6, 2012)
  • K082087 — EYEFEEL OPHTHALMIC WARMER (September 11, 2008)
  • K071710 — BENGAY (R) HEAT THERAPY, PAIN RELIEVING PATCHES/PADS (VARIOUS) (August 14, 2007)
  • K021843 — EYEFEEL OPHTHALMIC WARMER (September 3, 2002)
  • K982652 — ALLEGIANCE PORTA-WARM MATTRESS (January 21, 1999)
  • K980509 — DEROYAL INDUSTRIES, INC. INFANT TRANSPORT MATTRESS (February 26, 1998)
  • K974190 — CP&S INSTANT COLD PACK LIMB KIT TRANSPORTER (November 19, 1997)
  • K973770 — ALLEGIANCE KWIK HEAT WARM PERINEAL PACK (November 13, 1997)

FDA data resources