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510(k) K180880

DARI Health by Scientific Analytics, Inc. — Product Code LXJ

K180880 is an FDA 510(k) premarket notification submitted by Scientific Analytics, Inc. for the device "DARI Health". The FDA issued a decision of Substantially Equivalent on March 7, 2019. 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
March 7, 2019
Date Received
April 3, 2018
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)
  • 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