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Amico Diagnostic Rollstand

Model DS-UR1-CHFH-DXX · Amico Diagnostic Incorporated · DI 00697077001643

ERA — Otoscope · Class I · 21 CFR 874.4770

HLI — Ophthalmoscope, Ac-Powered · Class II · 21 CFR 886.1570

UDILibrary device dossier · generated 2026-09-13 · 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.

01112020-08: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device0810
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-0801
2022-1001
This device (reports/month)Average device in ERA, HLI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Amico Diagnostic Incorporated

  • VAI 2016-10-27 Amico Diagnostic Incorporated · 7 citations
  • VAI 2016-10-27 Amico Diagnostic Incorporated · 7 citations