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510(k) K801625

THERMOLATOR HEATING UNIT by Tru-Eze Mfg. Co., Inc. — Product Code IRQ

K801625 is an FDA 510(k) premarket notification submitted by Tru-Eze Mfg. Co., Inc. for the device "THERMOLATOR HEATING UNIT". The FDA issued a decision of Substantially Equivalent on July 28, 1980. The device falls under product code IRQ (Unit, Heating, Powered), a Class I device regulated under 21 CFR 890.5950. Tru-Eze Mfg. Co., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1980
Date Received
July 15, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Heating, Powered
Device Class
Class I
Regulation Number
890.5950
Review Panel
PM
Submission Type

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

  • K800917 — TRU-COLD THERAPY PAK (May 2, 1980)
  • K791653 — REUSABLE MOIST HEAT PACK (September 7, 1979)

Other clearances for product code IRQ

  • K050524 — EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 (September 14, 2005)
  • K950350 — THEMALATOR. MODELS T-4-S, T-8-S, ETC. (March 24, 1995)
  • K924023 — FERNO ILLE INFERNO MOIST HEAT THERAPY UT, 916/917 (April 14, 1993)
  • K880644 — ULTRA-PAN FOR ORTHOTIC PLASTICS (7262) (May 6, 1988)
  • K861340 — R1750 AND R1424 POWERED HEATING UNITS (May 2, 1986)
  • K832177 — PULSAIR MODEL SP-1 (December 9, 1983)

FDA data resources