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510(k) K192474

VERA by Reflexion Health, Inc. — Product Code LXJ

K192474 is an FDA 510(k) premarket notification submitted by Reflexion Health, Inc. for the device "VERA". The FDA issued a decision of Substantially Equivalent on October 10, 2019. The device falls under product code LXJ (Interactive Rehabilitation Exercise Devices), a Class II device regulated under 21 CFR 890.5360. Reflexion Health, Inc. has at least 2 other 510(k) clearances on record.

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)

FDA data resources