510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
DEN250044Unknown

STEMI AI ECG Model

Powerful Medical, Inc., New York CA / Direct, Unknown
FDA source (opens on fda.gov)

Clearance record

Decision date
Received
(346 days to decision)
Product code
SHS
Review panel
Unknown
Applicant
Powerful Medical, Inc. 7th Floor, 33 W. 17th St., New York CA
Third party review
No

Clearances, product code SHS

Trailing 12 months
1 clearance under product code SHS in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SHS, 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 20261
October 20260