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510(k) K800917

TRU-COLD THERAPY PAK by Tru-Eze Mfg. Co., Inc. — Product Code IME

K800917 is an FDA 510(k) premarket notification submitted by Tru-Eze Mfg. Co., Inc. for the device "TRU-COLD THERAPY PAK". The FDA issued a decision of Substantially Equivalent on May 2, 1980. The device falls under product code IME (Pack, Hot Or Cold, Reusable), a Class I device regulated under 21 CFR 890.5700. Tru-Eze Mfg. Co., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1980
Date Received
April 22, 1980
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 Tru-Eze Mfg. Co., Inc.

  • K801625 — THERMOLATOR HEATING UNIT (July 28, 1980)
  • K791653 — REUSABLE MOIST HEAT PACK (September 7, 1979)

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)
  • K832193 — NICE PACK (August 31, 1983)
  • K831899 — ENSWELL (July 7, 1983)
  • K830981 — MICROPAK MOIST HEAT PAD (June 3, 1983)
  • K830416 — ICY COLD ICE CAP (March 10, 1983)

FDA data resources