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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K253088
Device Name OneStim-DUO Cardiac Stimulator (MP5003-4CO)
Applicant
Micropace Pty, Ltd.
Unit 41, 159 Arthur St.
Homebush W.,  AU 2140
Applicant Contact Michael Cejnar
Correspondent
Acorn N Oakes, LLC
333 N. Dobson Rd. Vo5
Chandler,  AZ  85224
Correspondent Contact Amy Oakes
Regulation Number870.1425
Classification Product Code
DQK  
Subsequent Product Code
JOQ  
Date Received09/23/2025
Decision Date 06/12/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 Yes
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