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510(k) K861340

R1750 AND R1424 POWERED HEATING UNITS by Tri W-G, Inc. — Product Code IRQ

K861340 is an FDA 510(k) premarket notification submitted by Tri W-G, Inc. for the device "R1750 AND R1424 POWERED HEATING UNITS". The FDA issued a decision of Substantially Equivalent on May 2, 1986. The device falls under product code IRQ (Unit, Heating, Powered), a Class I device regulated under 21 CFR 890.5950. Tri W-G, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1986
Date Received
April 7, 1986
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 Tri W-G, Inc.

  • K960196 — TRI W-G, INC TABLE, TILT/EXAM/TREATMENT MODEL 777 (February 7, 1996)
  • K945163 — ECHOCARDIOGRAPHY (February 17, 1995)
  • K941720 — MODEL 747 AND 747-30 EXAM/TREATMENT TABLE (May 6, 1994)
  • K936303 — TREATMENT TABLE MODIFICATION (March 18, 1994)
  • K933119 — HI-LO TREATMENT TABLES (October 12, 1993)
  • K932746 — MODEL T4501,T4502,T4503,T4504,T4504 TILT TABLE (July 21, 1993)
  • K930802 — MODELS 642 & 643 TILT EXAM/TREATMENT TABLE (March 22, 1993)
  • K925594 — MDL 29001 MEDI ELEC-MECH TILT EXAM/TREATMENT TABLE (February 12, 1993)
  • K923325 — MODEL 600 MEDICAL TREATMENT TABLE (July 21, 1992)
  • K922980 — 745-M (MAGNUM) (July 13, 1992)

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)
  • K832177 — PULSAIR MODEL SP-1 (December 9, 1983)
  • K801625 — THERMOLATOR HEATING UNIT (July 28, 1980)

FDA data resources