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510(k) K192474

VERA by Reflexion Health, Inc. — Product Code LXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 10, 2019
Date Received
September 10, 2019
Clearance Type
Special
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 by Reflexion Health, Inc.

  • K182333 — Vera (April 9, 2019)
  • K150462 — Vera (October 30, 2015)

Other clearances for product code LXJ

  • 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)
  • K163245 — Virtual Occupational Therapy Application (VOTA) (February 28, 2017)
  • K151955 — YuGo System (February 5, 2016)
  • K150462 — Vera (October 30, 2015)
  • K151446 — Recovr Rehabilitation System (September 18, 2015)