510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K123539Substantially Equivalent

Stayhealthy Health Kiosk, Stayhealthy Healthcenter Kiosk

Stayhealthy, Inc., Monrovia CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K123539 is the FDA 510(k) clearance record for STAYHEALTHY HEALTH KIOSK, STAYHEALTHY HEALTHCENTER KIOSK, a class II device, cleared for Stayhealthy, Inc. on under FDA product code DXN (System, Measurement, Blood-Pressure, Non-Invasive). FDA records list 3 510(k) clearances for Stayhealthy, Inc., from to . As of , FDA records show no recalls naming K123539.

Clearance record

Decision date
Received
(157 days to decision)
Product code
DXN System, Measurement, Blood-Pressure, Non-Invasive
Regulation
21 CFR 870.1130
Device class
Class II
Review panel
Cardiovascular
Applicant
Stayhealthy, Inc. 24 E. Hungtington Dr., Monrovia CA
510(k) summary
Statement
Third party review
Yes

Clearances, product code DXN

Trailing 12 months
30 clearances under product code DXN in the twelve months to October 2026, April 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DXN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20264
March 20262
April 20265
May 20263
June 20264
July 20262
August 20264
September 20262
October 20261