510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K963904Substantially Equivalent

P.h.d. - Personal Heart Device Model 5258

Heart Alert, Inc., Douglasville GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963904 is the FDA 510(k) clearance record for P.H.D. - PERSONAL HEART DEVICE MODEL 5258, a class II device, cleared for Heart Alert, Inc. on under FDA product code DXH (Transmitters And Receivers, Electrocardiograph, Telephone). FDA records list one 510(k) clearance for Heart Alert, Inc. As of , FDA records show no recalls naming K963904.

Clearance record

Decision date
Received
(227 days to decision)
Product code
DXH Transmitters And Receivers, Electrocardiograph, Telephone
Regulation
21 CFR 870.2920
Device class
Class II
Review panel
Cardiovascular
Applicant
Heart Alert, Inc. 6140 Central Church Rd., Douglasville GA
510(k) summary
Statement
Third party review
No

Clearances, product code DXH

Trailing 12 months
4 clearances under product code DXH in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code DXH, trailing twelve months
MonthClearances
November 20251
December 20252
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260