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510(k) K884926

BALANCE SYSTEM by Chattanooga Group, Inc. — Product Code LXV

K884926 is an FDA 510(k) premarket notification submitted by Chattanooga Group, Inc. for the device "BALANCE SYSTEM". The FDA issued a decision of Substantially Equivalent on February 27, 1989. The device falls under product code LXV (Apparatus, Vestibular Analysis), a Class U device. Chattanooga Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1989
Date Received
November 28, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Vestibular Analysis
Device Class
Class U
Regulation Number
Review Panel
EN
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 LXV

  • K220231 — GyroStim (April 27, 2022)
  • K200529 — Orion (August 12, 2020)
  • K192652 — TRV (May 27, 2020)
  • K183661 — ClearEdge Balance System (October 22, 2019)
  • K190735 — EQ Balance (August 16, 2019)
  • K173669 — K-D Balance (April 2, 2018)
  • K121590 — VESTIBULAR ANALYSIS APPARATUS (September 20, 2012)
  • K102364 — NYDIAG 200 (December 23, 2010)
  • K082634 — VERTIGONE BPPV GOGGLE (April 7, 2009)
  • K081602 — DIZZYFIX (September 19, 2008)

FDA data resources