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Unnamed device
Model NONE · Neurovision Medical Products, Inc. · DI B006NVHS102
BTR — Tube, Tracheal (W/Wo Connector) · Class II · 21 CFR 868.5730
ETN — Stimulator, Nerve · Class II · 21 CFR 874.1820
GWF — Stimulator, Electrical, Evoked Response · Class II · 21 CFR 882.1870
UDILibrary device dossier · generated 2026-09-07 · 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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
2.48
2019-02
0
3.11
2019-03
0
2.67
2019-04
0
2.3
2019-05
0
2.16
2019-06
0
1.87
2019-07
0
2.08
2019-08
0
3.07
2019-09
0
3.47
2019-10
0
3.49
2019-11
0
3.72
2019-12
0
3.31
2020-01
0
2.92
2020-02
0
2.1
2020-03
0
3.07
2020-04
0
2.4
2020-05
0
2.52
2020-06
0
2.22
2020-07
0
2.67
2020-08
0
2.77
2020-09
0
2.51
2020-10
0
3.38
2020-11
0
2.66
2020-12
0
2.45
2021-01
0
1.9
2021-02
0
2.35
2021-03
0
2.05
2021-04
0
2.24
2021-05
0
2.02
2021-06
0
2.72
2021-07
0
2.97
2021-08
0
2.44
2021-09
0
2.87
2021-10
0
2.53
2021-11
0
2.31
2021-12
0
1.73
2022-01
0
2.01
2022-02
0
1.9
2022-03
0
1.71
2022-04
0
2.4
2022-05
0
2.72
2022-06
0
2.35
2022-07
0
1.84
2022-08
0
2.1
2022-09
0
2.19
2022-10
0
2.34
2022-11
0
2.15
2022-12
0
2.34
2023-01
0
2.62
2023-02
0
2.21
2023-03
0
2.32
2023-04
0
1.8
2023-05
0
2.62
2023-06
0
2.41
2023-07
0
2.05
2023-08
0
2.79
2023-09
0
3.12
2023-10
0
5.31
2023-11
0
5.08
2023-12
0
5.53
2024-01
0
3.98
2024-02
0
5.03
2024-03
0
4.91
2024-04
0
6.16
2024-05
0
5.81
2024-06
0
5.01
2024-07
0
7.35
2024-08
0
9.36
2024-09
0
11.65
2024-10
0
9.94
2024-11
0
8.91
2024-12
0
6.73
2025-01
0
6.92
2025-02
0
10.92
2025-03
0
10.6
2025-04
0
7.97
2025-05
0
6.66
2025-06
0
6.91
2025-07
0
10.75
2025-08
0
6.29
2025-09
0
6.89
2025-10
0
10.58
2025-11
0
8.53
2025-12
0
8.94
2026-01
0
6.48
2026-02
0
6.76
2026-03
0
9.09
2026-04
0
8.05
2026-05
0
8.69
2026-06
0
8.4
This device (reports/month)Average device in BTR, ETN, GWF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K110989 — cites (transitively): K094054 (d1), K032491 (d2), K090298 (d2) — cited as predicate by K221821, K242852
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Neurovision Medical Products, Inc.
NAI 2024-02-13 Neurovision Medical Products Inc · 0 citations
NAI 2024-02-13 Neurovision Medical Products Inc · 0 citations
VAI 2016-09-30 Neurovision Medical Products Inc · 3 citations
VAI 2016-09-30 Neurovision Medical Products Inc · 3 citations
VAI 2012-11-20 Neurovision Medical Products Inc · 2 citations
VAI 2012-11-20 Neurovision Medical Products Inc · 2 citations
NAI 2010-09-22 Neurovision Medical Products Inc · 0 citations
NAI 2010-09-22 Neurovision Medical Products Inc · 0 citations