510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943559Substantially Equivalent

Remote A'lert

Health Sense Intl., Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943559 is the FDA 510(k) clearance record for REMOTE A'LERT, a class II device, cleared for Health Sense Intl., Inc. on under FDA product code KPN (Alarm, Conditioned Response Enuresis). FDA records list 4 510(k) clearances for Health Sense Intl., Inc., from to . As of , FDA records show no recalls naming K943559.

Clearance record

Decision date
Received
(306 days to decision)
Product code
KPN Alarm, Conditioned Response Enuresis
Regulation
21 CFR 876.2040
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Health Sense Intl., Inc. 555 Thirteenth St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code KPN

Trailing 12 months

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

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