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510(k) K190735

EQ Balance by Upright Science, Inc. — Product Code LXV

K190735 is an FDA 510(k) premarket notification submitted by Upright Science, Inc. for the device "EQ Balance". The FDA issued a decision of Substantially Equivalent on August 16, 2019. The device falls under product code LXV (Apparatus, Vestibular Analysis), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2019
Date Received
March 21, 2019
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 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)
  • 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)
  • K071973 — EPLEY OMNIAX (June 20, 2008)

FDA data resources