Print-ready dossier — use your browser's print dialog to save as PDF.
ViVi Helmet HPL
Model 80130 · THI Total Healthcare Innovation GmbH · DI 09009607801301
FXY — Hood, Surgical · Class II · 21 CFR 878.4040
UDILibrary device dossier · generated 2026-09-11 · 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
1
2019-10
0
1
2020-04
0
1
2022-07
0
1
2023-01
0
1
2023-10
0
1
2024-01
0
1
2024-04
0
1
2024-07
0
1
2024-10
0
1
2025-01
0
1
2025-04
0
1
2025-07
0
1
This device (reports/month)Average device in FXY (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — THI Total Healthcare Innovation GmbH