Warning letterPosted July 14, 2026
FDA warning letter to Nihon Kohden Digital Health Solutions, LLC
Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
FDA posted a warning letter to Nihon Kohden Digital Health Solutions, LLC on July 14, 2026; the letter is dated June 12, 2026. Subject: Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k). Issuing office: Center for Devices and Radiological Health.
On the record
- Company
- Nihon Kohden Digital Health Solutions, LLC
- Subject
- Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
- Issuing office
- Center for Devices and Radiological Health
- Letter dated
- 2026-06-12
- Posted by FDA
- 2026-07-14
- Source
- FDA warning letters ↗
CFR cited
The record cites 2 sections of 21 CFR Parts 807 and 870.
The full record
An account shows the violations FDA described and each CFR section it cited.
What a warning letter is
A warning letter is FDA's notice to a company that it found significant violations of federal requirements. FDA asks for a written response, normally within 15 working days. The letter is advisory: it states the agency's position and is not a final agency action.
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