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510(k) K980718

PARA-CARE by Chattanooga Group, Inc. — Product Code IMC

K980718 is an FDA 510(k) premarket notification submitted by Chattanooga Group, Inc. for the device "PARA-CARE". The FDA issued a decision of Substantially Equivalent on March 27, 1998. The device falls under product code IMC (Bath, Paraffin), a Class II device regulated under 21 CFR 890.5110. Chattanooga Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 1998
Date Received
February 24, 1998
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 Chattanooga Group, Inc.

  • K090632 — COMPEX REHAB (June 1, 2009)
  • K083433 — INTELECT SWD 100, MODEL 1600; SENIOR SOLUTIONS SHORTWAVE DIATHERMY, MODEL 1601 (March 18, 2009)
  • K083140 — COMPEX SPORT PLUS (February 9, 2009)
  • K070425 — VITALSTIM EXPERIA (June 11, 2007)
  • K053223 — TRITON/TRU-TRAC/TX/TRITON DTS TRACTION (February 24, 2006)
  • K051938 — TRITON/TRU-TRAC/TX TRACTION DEVICES (September 21, 2005)
  • K040662 — VECTRA GENISYS (MODULE & TRANSPORTABLE) AND INTELECT XT (MODULE & TRANSPORTABLE) (September 8, 2004)
  • K040285 — VECTRA TRANSPORTABLE COMBO AND STIM (SPECIALTY LINE DEALERS); INTELECT TRANSPORT (April 12, 2004)
  • K031077 — VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM (December 11, 2003)
  • K031116 — VECTRA (INTELECT) EPR ULTRASOUND (December 3, 2003)

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)
  • K861344 — R1124 & R1686 PARAFFIN (May 27, 1986)
  • K861346 — R1363 PARAFFIN (May 2, 1986)
  • K842423 — PARA THERM BATH (June 28, 1984)
  • K833631 — THERMAMED BATH (November 28, 1983)

FDA data resources