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621 INSIGNIA

Model 621P · SIGVARIS INC · DI 00745129221683

DWL — Stocking, Medical Support (To Prevent Pooling Of Blood In Legs) · Class II · 21 CFR 880.5780

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.

12232021-05: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 3/device2025-05: 0 reports for this device; peer average 1.33/device051005
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2021-0501
2023-1003
2025-0501.33
This device (reports/month)Average device in DWL (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — SIGVARIS INC

  • VAI 2025-01-16 SIGVARIS AG · 0 citations
  • NAI 2019-09-24 Sigvaris, Inc. · 0 citations
  • NAI 2015-11-10 Sigvaris, Inc. · 0 citations