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"Knee Immobilizer S/A, Super-Lite, 28"""

Model E62651 · DARCO INTERNATIONAL, INC. · DI 00609271611481

ITQ — Joint, Knee, External Brace · Class I · 21 CFR 890.3475

UDILibrary device dossier · generated 2026-09-14 · 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.

11222024-08: 0 reports for this device; peer average 2/device2024-09: 0 reports for this device; peer average 2/device0809
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2024-0802
2024-0902
This device (reports/month)Average device in ITQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — DARCO INTERNATIONAL, INC.

  • NAI 2018-11-14 DARCO International Inc · 0 citations
  • NAI 2018-11-14 DARCO International Inc · 0 citations
  • VAI 2015-06-16 DARCO International Inc · 5 citations
  • VAI 2015-06-16 DARCO International Inc · 5 citations