FDA Product Code MWJ: Electrocardiograph, Ambulatory (without Analysis)
Leading manufacturers include Heartbeam, Inc., Kestra Medical Technologies, Inc. and Medicalgorithmics S.A..
FDA 510(k) Cleared Electrocardiograph, Ambulatory (without Analysis) Devices (Product Code MWJ)
About Product Code MWJ - Regulatory Context
510(k) Submission Activity
59 total 510(k) submissions under product code MWJ since 1998, with 59 receiving FDA clearance (average review time: 140 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA Review Time
Recent submissions under MWJ have taken an average of 576 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.
MWJ devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →