510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211463Substantially Equivalent

Regulora

Metame Health, Inc., Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211463 is the FDA 510(k) clearance record for Regulora, a class II device, cleared for Metame Health, Inc. on under FDA product code QMY (Computerized Behavioral Therapy Device For Treating Symptoms). FDA's definition for product code QMY reads: "A computerized behavioral therapy device for treating symptoms of gastrointestinal conditions is a prescription device intended to provide a computerized version of condition-specific therapy as an adjunct to standard of care treatments to...". FDA records list one 510(k) clearance for Metame Health, Inc. As of , FDA records show no recalls naming K211463.

Clearance record

Decision date
Received
(197 days to decision)
Product code
QMY Computerized Behavioral Therapy Device For Treating Symptoms
Regulation
21 CFR 876.5960
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Metame Health, Inc. 222 W. Merchandise Mart Plz. - Suite 1230, Chicago IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QMY

Trailing 12 months

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

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