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510(k) K162748

MindMotionPRO by Mindmaze SA — Product Code LXJ

K162748 is an FDA 510(k) premarket notification submitted by Mindmaze SA for the device "MindMotionPRO". The FDA issued a decision of Substantially Equivalent on April 24, 2017. The device falls under product code LXJ (Interactive Rehabilitation Exercise Devices), a Class II device regulated under 21 CFR 890.5360. Mindmaze SA has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 2017
Date Received
September 30, 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 by Mindmaze SA

  • K173931 — MindMotion(TM) GO (May 17, 2018)

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)
  • 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