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# Nihon Kohden Marketing Adulterated, Misbranded Devices: FDA
- URL: https://www.fdaweb.com/nihon-kohden-marketing-adulterated-misbranded-devices-fda/
- Published: 2026-07-15T12:00:00.000Z
- Updated: 2026-09-14T13:42:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5161457

A 2/23-2/24 FDA inspection at Nihon Kohden Digital Health Solutions in Irvine, CA, determined that the firm manufactures the Next Generation NetKonnect software device, described as a patient physiological monitor device with an arrhythmia detector and alarm. A just-released 6/12 [Warning Letter](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/nihon-kohden-digital-health-solutions-llc-727803-06122026?ref=fdaweb.com) says the device is adulterated because Nihon does not have an approved PMA or IDE in effect for it. The device is misbranded, FDA says, because the company failed to notify the agency of its intent to begin commercial distribution of the unit.

FDA says the company implemented a 10/22/2022 software change to enable a silence alarms function but did not submit a new 510(k) because the company believed the change did not change a control mechanism of the device. FDA says it disagrees with this analysis because the change could significantly affect device safety or effectiveness.

The letter also says the company is distributing the device with an unauthorized intended use that is not covered in the original clearance.

Nihon was told to correct the violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with documentation of the actions and a schedule for completing the corrections.