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ADVANCE

Model NC-S94 · NeuroMetrix, Inc. · DI 00851221006247

JXE — Device, Nerve Conduction Velocity Measurement · Class II · 21 CFR 882.1550

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.

12232019-10: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 3/device2025-10: 0 reports for this device; peer average 2/device10031201061010
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1001
2020-0301
2022-1201
2023-0102
2023-0601
2024-1003
2025-1002
This device (reports/month)Average device in JXE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — NeuroMetrix, Inc.

  • NAI 2017-11-15 NeuroMetrix, Inc. · 0 citations
  • NAI 2017-11-15 NeuroMetrix, Inc. · 0 citations
  • VAI 2015-05-07 NeuroMetrix, Inc. · 1 citations
  • VAI 2015-05-07 NeuroMetrix, Inc. · 2 citations
  • VAI 2015-05-07 NeuroMetrix, Inc. · 1 citations
  • VAI 2015-05-07 NeuroMetrix, Inc. · 2 citations
  • VAI 2012-03-20 NeuroMetrix, Inc. · 2 citations
  • VAI 2012-03-20 NeuroMetrix, Inc. · 2 citations