510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180880Substantially Equivalent

DARI Health

Scientific Analytics, Inc., Lincoln NE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K180880 is the FDA 510(k) clearance record for DARI Health, a class II device, cleared for Scientific Analytics, Inc. on under FDA product code LXJ (Interactive Rehabilitation Exercise Devices). FDA records list one 510(k) clearance for Scientific Analytics, Inc. As of , FDA records show no recalls naming K180880.

Clearance record

Decision date
Received
(338 days to decision)
Product code
LXJ Interactive Rehabilitation Exercise Devices
Regulation
21 CFR 890.5360
Device class
Class II
Review panel
Physical Medicine
Applicant
Scientific Analytics, Inc. 2100 Magnum Cir., Suite 7, Lincoln NE
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LXJ

Trailing 12 months

FDA records hold no clearances under product code LXJ in the trailing twelve months.

FDA records show no clearances under product code LXJ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LXJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260