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3-Electrode Lead Patient Cable

Model M010331 · INTELLIGENT HEARING SYSTEMS CORP. · DI 00817020020105

IKD — Cable, Electrode · Class II · 21 CFR 890.1175

UDILibrary device dossier · generated 2026-09-11 · 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.

13452019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 1/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 1.5/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1.5/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 3/device2020-11: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1/device2021-03: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1.5/device2021-07: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 3/device2021-11: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 2.8/device2022-07: 0 reports for this device; peer average 3/device2022-08: 0 reports for this device; peer average 1.5/device2022-12: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1.5/device2023-08: 0 reports for this device; peer average 1.17/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 3/device2024-01: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 2/device2025-02: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1.5/device2025-06: 0 reports for this device; peer average 1.67/device2025-07: 0 reports for this device; peer average 3.5/device2025-08: 0 reports for this device; peer average 2.33/device2025-09: 0 reports for this device; peer average 1.5/device2025-10: 0 reports for this device; peer average 3.5/device2025-11: 0 reports for this device; peer average 3/device2025-12: 0 reports for this device; peer average 3/device2026-01: 0 reports for this device; peer average 2/device2026-02: 0 reports for this device; peer average 5/device2026-03: 0 reports for this device; peer average 2.2/device2026-04: 0 reports for this device; peer average 3/device2026-05: 0 reports for this device; peer average 2.14/device2026-06: 0 reports for this device; peer average 2.5/device03040607080901020305060809110102030406070811050607081203081011010304050611020406070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0301
2019-0401
2019-0601
2019-0701
2019-0803
2019-0901
2020-0101
2020-0202
2020-0301.5
2020-0501
2020-0601.5
2020-0801
2020-0903
2020-1101
2021-0101
2021-0201
2021-0301
2021-0401
2021-0601.5
2021-0701
2021-0803
2021-1101
2022-0501
2022-0602.8
2022-0703
2022-0801.5
2022-1201
2023-0301.5
2023-0801.17
2023-1001
2023-1103
2024-0101
2024-0301
2024-0402
2024-0501
2024-0601
2024-1102
2025-0201
2025-0401.5
2025-0601.67
2025-0703.5
2025-0802.33
2025-0901.5
2025-1003.5
2025-1103
2025-1203
2026-0102
2026-0205
2026-0302.2
2026-0403
2026-0502.14
2026-0602.5
This device (reports/month)Average device in IKD (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — INTELLIGENT HEARING SYSTEMS CORP.

  • NAI 2017-06-02 Intelligent Hearing Systems Corp. · 0 citations
  • NAI 2017-06-02 Intelligent Hearing Systems Corp. · 0 citations
  • VAI 2013-01-22 Intelligent Hearing Systems Corp. · 8 citations
  • VAI 2013-01-22 Intelligent Hearing Systems Corp. · 8 citations