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Armeo
Model Power · HOCOMA AG · DI 07640174660193
IKK — System, Isokinetic Testing And Evaluation · Class II · 21 CFR 890.1925
ION — Exerciser, Non-Measuring · Class I · 21 CFR 890.5370
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)
2019-04
0
2
2019-06
0
1
2019-09
0
1
2019-10
0
1
2019-11
0
1
2020-03
0
1
2021-06
0
3
2021-07
0
1.5
2021-12
0
1
2022-04
0
1
2022-12
0
1
2023-04
0
1
2023-10
0
3
2023-11
0
1
2024-03
0
2
2025-05
0
2
2026-01
0
2.5
2026-03
0
7
2026-04
0
1.5
This device (reports/month)Average device in IKK, ION (reports/device/month)