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"""VitalPatch™ Gentle Patch"
Model 3001-01 · Vital Connect, Inc. · DI 00850490007054
DRG — Transmitters And Receivers, Physiological Signal, Radiofrequency · Class II · 21 CFR 870.2910
DSI — Detector And Alarm, Arrhythmia · Class II · 21 CFR 870.1025
MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) · Class II · 21 CFR 870.1025
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.
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
18.41
2019-02
0
13.07
2019-03
0
23.32
2019-04
0
14.69
2019-05
0
13.49
2019-06
0
11.42
2019-07
0
16.19
2019-08
0
11.95
2019-09
0
16.29
2019-10
0
14.97
2019-11
0
19.54
2019-12
0
14.31
2020-01
0
14.25
2020-02
0
16.03
2020-03
0
14.36
2020-04
0
9.88
2020-05
0
9.44
2020-06
0
11.4
2020-07
0
13.68
2020-08
0
10.79
2020-09
0
11.07
2020-10
0
11.35
2020-11
0
16.43
2020-12
0
12.86
2021-01
0
8.67
2021-02
0
12.42
2021-03
0
15.45
2021-04
0
19.88
2021-05
0
12.74
2021-06
0
13.83
2021-07
0
14.5
2021-08
0
15.23
2021-09
0
15.15
2021-10
0
11.11
2021-11
0
12.06
2021-12
0
12.45
2022-01
0
11
2022-02
0
10.1
2022-03
0
10.42
2022-04
0
10.23
2022-05
0
9.8
2022-06
0
6.61
2022-07
0
8.86
2022-08
0
9.59
2022-09
0
7.35
2022-10
0
10.34
2022-11
0
8.36
2022-12
0
8.19
2023-01
0
7.55
2023-02
0
9.6
2023-03
0
15.45
2023-04
0
10.84
2023-05
0
12.74
2023-06
0
10.86
2023-07
0
10.79
2023-08
0
11.97
2023-09
0
13.33
2023-10
0
11.17
2023-11
0
9.49
2023-12
0
11.07
2024-01
0
10.81
2024-02
0
11.72
2024-03
0
11.96
2024-04
0
9.64
2024-05
0
13.32
2024-06
0
11.2
2024-07
0
8.83
2024-08
0
11.57
2024-09
0
9.78
2024-10
0
14.09
2024-11
0
11.59
2024-12
0
9.42
2025-01
0
13.11
2025-02
0
11.17
2025-03
0
15.33
2025-04
0
10.87
2025-05
0
13.79
2025-06
0
14.67
2025-07
0
17.41
2025-08
0
14.86
2025-09
0
11.94
2025-10
0
19.31
2025-11
0
14.88
2025-12
0
17.18
2026-01
0
15.2
2026-02
0
18.74
2026-03
0
19.85
2026-04
0
19.39
2026-05
0
20.59
2026-06
0
18.98
This device (reports/month)Average device in DRG, DSI, MHX (reports/device/month)