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510(k) K861346

R1363 PARAFFIN by Tri W-G, Inc. — Product Code IMC

K861346 is an FDA 510(k) premarket notification submitted by Tri W-G, Inc. for the device "R1363 PARAFFIN". The FDA issued a decision of Substantially Equivalent on May 2, 1986. The device falls under product code IMC (Bath, Paraffin), a Class II device regulated under 21 CFR 890.5110. 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
Bath, Paraffin
Device Class
Class II
Regulation Number
890.5110
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 IMC

  • K093100 — REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) (November 24, 2009)
  • K022626 — MOISTURESTAY (REVLON) (October 29, 2002)
  • K013707 — SOFTIQUE, MODEL GI 11001 (February 1, 2002)
  • K013328 — REMINGTON PARAFFIN SPA, MODELS HS-200. PFS-600 (December 3, 2001)
  • K001860 — PARASPA PARAFFIN BATH, PARASPAP MINI, PARASPA ULTRA (August 10, 2000)
  • K991427 — PARAMED PARAFFIN WARMER (August 13, 1999)
  • K980718 — PARA-CARE (March 27, 1998)
  • K861344 — R1124 & R1686 PARAFFIN (May 27, 1986)
  • K842423 — PARA THERM BATH (June 28, 1984)
  • K833631 — THERMAMED BATH (November 28, 1983)

FDA data resources