510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K220231Substantially Equivalent

GyroStim

Ultrathera Technologies, Inc., Colorado Springs CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K220231 is the FDA 510(k) clearance record for GyroStim, cleared for Ultrathera Technologies, Inc. on under FDA product code LXV (Apparatus, Vestibular Analysis). FDA records list one 510(k) clearance for Ultrathera Technologies, Inc. As of , FDA records show no recalls naming K220231.

Clearance record

Decision date
Received
(90 days to decision)
Product code
LXV Apparatus, Vestibular Analysis
Device class
Unclassified
Review panel
Unknown
Applicant
Ultrathera Technologies, Inc. 2 N. Cascade Ave., Suite 640, Colorado Springs CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LXV

Trailing 12 months

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

FDA records show no clearances under product code LXV in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LXV, 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