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510(k) K150462

Vera by Reflexion Health, Inc. — Product Code LXJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 2015
Date Received
February 23, 2015
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 by Reflexion Health, Inc.

  • K192474 — VERA (October 10, 2019)
  • K182333 — Vera (April 9, 2019)

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