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510(k) K936084

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1994
Date Received
December 21, 1993
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.

  • K961176 — OMNI COLD GEL PACKS (September 4, 1996)
  • K955788 — IMNI HOT PACKS (September 4, 1996)
  • K954877 — OMNI COLD GEL PACKS (February 13, 1996)
  • 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)