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APEX
Model WiZARD 320 · Wellell Inc. · DI 04719893334173
BZD — Ventilator, Non-Continuous (Respirator) · Class II · 21 CFR 868.5905
UDILibrary device dossier · generated 2026-09-06 · 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
2.67
2019-02
0
1.33
2019-03
0
1.25
2019-04
0
1.88
2019-05
0
1.91
2019-06
0
1.33
2019-07
0
2.43
2019-08
0
1.33
2019-09
0
1.2
2019-10
0
1.4
2019-11
0
1.5
2019-12
0
1.5
2020-01
0
1.55
2020-02
0
2.17
2020-03
0
1.6
2020-04
0
1.5
2020-05
0
2
2020-06
0
2
2020-07
0
1.33
2020-08
0
2.33
2020-09
0
1.25
2020-10
0
1.67
2020-11
0
1
2020-12
0
1.83
2021-02
0
2
2021-03
0
2.2
2021-04
0
2
2021-05
0
4.81
2021-06
0
3.63
2021-07
0
4.64
2021-08
0
8.99
2021-09
0
8.19
2021-10
0
10.43
2021-11
0
10.12
2021-12
0
11.27
2022-01
0
23.23
2022-02
0
27.05
2022-03
0
25.55
2022-04
0
31.16
2022-05
0
78.89
2022-06
0
147.93
2022-07
0
132.07
2022-08
0
68.39
2022-09
0
54.34
2022-10
0
31.75
2022-11
0
34.73
2022-12
0
24.59
2023-01
0
30.93
2023-02
0
19.79
2023-03
0
12.85
2023-04
0
14.27
2023-05
0
19.74
2023-06
0
13.85
2023-07
0
16.64
2023-08
0
19.74
2023-09
0
15.97
2023-10
0
14.69
2023-11
0
22.58
2023-12
0
34.64
2024-01
0
30.64
2024-02
0
31.69
2024-03
0
34.06
2024-04
0
47.2
2024-05
0
54.67
2024-06
0
50.79
2024-07
0
45.23
2024-08
0
63.06
2024-09
0
54.2
2024-10
0
66.51
2024-11
0
49.45
2024-12
0
29.62
2025-01
0
38.98
2025-02
0
160.13
2025-03
0
160.72
2025-04
0
39.32
2025-05
0
14.4
2025-06
0
18.39
2025-07
0
13.98
2025-08
0
6.77
2025-09
0
8.36
2025-10
0
8.59
2025-11
0
98.48
2025-12
0
9.14
2026-01
0
23.24
2026-02
0
44.59
2026-03
0
42.56
2026-04
0
7.62
2026-05
0
100
2026-06
0
145.14
This device (reports/month)Average device in BZD (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Wellell Inc.
NAI 2015-02-04 Apex Medical (Kunshan) Corp. · 2 citations
VAI 2014-11-07 Wellell Inc · 0 citations
VAI 2014-11-07 Wellell Inc · 0 citations
VAI 2012-02-23 Wellell Inc · 2 citations
VAI 2012-02-23 Wellell Inc · 2 citations
NAI 2011-12-01 Apex Medical (Kunshan) Corp. · 0 citations