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510(k) K070676

KOREBALANCE (KINESTHETIC ABILITY TRAINER) by Sportkat, LLC — Product Code LXV

K070676 is an FDA 510(k) premarket notification submitted by Sportkat, LLC for the device "KOREBALANCE (KINESTHETIC ABILITY TRAINER)". The FDA issued a decision of Substantially Equivalent on April 18, 2007. The device falls under product code LXV (Apparatus, Vestibular Analysis), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2007
Date Received
March 12, 2007
Clearance Type
Special
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 for product code LXV

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  • 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