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510(k) K151446

Recovr Rehabilitation System by Recovr,Inc — Product Code LXJ

K151446 is an FDA 510(k) premarket notification submitted by Recovr,Inc for the device "Recovr Rehabilitation System". The FDA issued a decision of Substantially Equivalent on September 18, 2015. 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
September 18, 2015
Date Received
May 29, 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 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)
  • K150462 — Vera (October 30, 2015)

FDA data resources