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AE-120A EEG Head Set

Model YZ-003A4 · NIHON KOHDEN CORPORATION · DI 04931921903582

OMC — Reduced- Montage Standard Electroencephalograph · Class II · 21 CFR 882.1400

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

12352021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 4.33/device2024-04: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 2/device2025-04: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 1.25/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 4/device2026-03: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 4.5/device2026-05: 0 reports for this device; peer average 1.5/device2026-06: 0 reports for this device; peer average 2/device09100505040901020304060708101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0902
2021-1001
2022-0501
2023-0504.33
2024-0401
2024-0901
2025-0101
2025-0202
2025-0302
2025-0402
2025-0601.25
2025-0701
2025-0802
2025-1001
2025-1101
2025-1201
2026-0103
2026-0204
2026-0303
2026-0404.5
2026-0501.5
2026-0602
This device (reports/month)Average device in OMC (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — NIHON KOHDEN CORPORATION

  • Warning Letter 2026-06-15 Nihon Kohden Digital Health Solutions, LLC.
  • NAI 2026-01-13 Nihon Kohden America Fulfillment Center · 0 citations
  • VAI 2024-10-04 Nihon Kohden America LLC · 0 citations
  • NAI 2024-01-26 Nihon Kohden Kawamoto Corp. · 0 citations
  • VAI 2024-01-24 Nihon Kohden Corporation - Tokorozawa Technical Center · 0 citations
  • NAI 2023-06-13 Nihon Kohden Digital Health Solutions, LLC. · 0 citations
  • NAI 2021-05-03 Nihon Kohden America LLC · 0 citations
  • VAI 2019-04-30 Nihon Kohden America LLC · 6 citations
  • NAI 2017-10-26 Nihon Kohden America LLC · 0 citations
  • NAI 2016-05-13 Nihon Kohden Digital Health Solutions, LLC. · 0 citations
  • NAI 2016-03-25 Nihon Kohden Tomioka Corporation · 0 citations
  • VAI 2014-04-24 Nihon Kohden America LLC · 0 citations
  • NAI 2011-12-13 Nihon Kohden Corp. · 0 citations
  • NAI 2011-12-13 Nihon Kohden Corp. · 0 citations
  • NAI 2011-12-12 Nihon Kohden Kawamoto Corp. · 0 citations
  • NAI 2011-12-09 Nihon Kohden Tomioka Corporation · 0 citations
  • NAI 2011-08-05 Nihon Kohden Digital Health Solutions, LLC. · 0 citations