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510(k) K791653

REUSABLE MOIST HEAT PACK by Tru-Eze Mfg. Co., Inc. — Product Code IMA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1979
Date Received
August 14, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pack, Heat, Moist
Device Class
Class I
Regulation Number
890.5730
Review Panel
PM
Submission Type

Other clearances by Tru-Eze Mfg. Co., Inc.

  • K801625 — THERMOLATOR HEATING UNIT (July 28, 1980)
  • K800917 — TRU-COLD THERAPY PAK (May 2, 1980)

Other clearances for product code IMA

  • K150139 — Rachel's Remedy (May 22, 2015)
  • K950701 — WAHL SPORTS RELIEF HOT/COLD MASSAGER ROLLER (March 24, 1995)
  • K841698 — HEAT PACK (May 10, 1984)
  • K832803 — STEAM PAK MOIST HEAT (September 20, 1983)
  • K823622 — INSULATED THERMOELASTOMER MITT (December 30, 1982)
  • K803177 — MOIST HEAT PACK (December 31, 1980)
  • K790904 — STAO-HOTPACK (May 18, 1979)