Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Bertec Head Mounted Display System (HMD)

Model 97P-0109 · BERTEC CORPORATION · DI 00850017250116

ISD — Exerciser, Measuring · Class II · 21 CFR 890.5360

KHX — Platform, Force-Measuring · Class I · 21 CFR 890.1575

UDILibrary device dossier · generated 2026-09-15 · 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.

11222019-07: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 2/device2026-04: 0 reports for this device; peer average 1/device2026-05: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 1/device071209040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0701
2021-1201
2025-0902
2026-0401
2026-0501
2026-0601
This device (reports/month)Average device in ISD, KHX (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — BERTEC CORPORATION

  • VAI 2024-02-12 Bertec Corp · 1 citations
  • VAI 2024-02-12 Bertec Corp · 1 citations