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Main Cable/Plug Med4
Model 9001C01 · Otto Bock Healthcare Products GmbH · DI 04032767648771
IPF — Stimulator, Muscle, Powered · Class II · 21 CFR 890.5850
UDILibrary device dossier · generated 2026-09-12 · 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)
2019-02
0
1
2019-06
0
2
2019-10
0
1.5
2019-11
0
4
2019-12
0
2
2020-02
0
2
2020-03
0
1
2020-06
0
2
2020-07
0
2
2020-09
0
2
2020-10
0
1
2020-11
0
1
2022-01
0
2
2022-06
0
2
2022-10
0
2
2023-05
0
1
2023-08
0
1
2023-09
0
1
2024-03
0
3.5
2024-06
0
1.5
2025-05
0
2
2025-06
0
1
2025-12
0
2
2026-01
0
8
2026-02
0
1
This device (reports/month)Average device in IPF (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K080950 — cited as predicate by K110179, K200088, K201290, K202648, K210002, K213622, K230701, K232786, K241488, K243828
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Otto Bock Healthcare Products GmbH
VAI 2019-11-21 Otto Bock Healthcare Products GmbH · 2 citations
VAI 2012-10-19 Otto Bock Healthcare Products GmbH · 5 citations
VAI 2012-10-17 Otto Bock Healthcare Products GmbH · 3 citations