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510(k) K163245

Virtual Occupational Therapy Application (VOTA) by Barron Associates, Inc. — Product Code LXJ

K163245 is an FDA 510(k) premarket notification submitted by Barron Associates, Inc. for the device "Virtual Occupational Therapy Application (VOTA)". The FDA issued a decision of Substantially Equivalent on February 28, 2017. The device falls under product code LXJ (Interactive Rehabilitation Exercise Devices), a Class II device regulated under 21 CFR 890.5360.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 2017
Date Received
November 18, 2016
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Interactive Rehabilitation Exercise Devices
Device Class
Class II
Regulation Number
890.5360
Review Panel
PM
Submission Type

Other clearances for product code LXJ

  • K192474 — VERA (October 10, 2019)
  • K182333 — Vera (April 9, 2019)
  • K180880 — DARI Health (March 7, 2019)
  • K171547 — Qualisys Clinical System (August 2, 2018)
  • K173931 — MindMotion(TM) GO (May 17, 2018)
  • K172882 — UINCARE HOME (May 10, 2018)
  • K162748 — MindMotionPRO (April 24, 2017)
  • K151955 — YuGo System (February 5, 2016)
  • K150462 — Vera (October 30, 2015)
  • K151446 — Recovr Rehabilitation System (September 18, 2015)

FDA data resources