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APEX

Model Pro-care Optima Prone Pump and Mattress · Wellell Inc. · DI 04713025005610

FMW — Cover, Mattress (Medical Purposes) · Class I · 21 CFR 880.6190

UDILibrary device dossier · generated 2026-09-07 · 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.

11222025-05: 0 reports for this device; peer average 2/device2025-10: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1/device05101201
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2025-0502
2025-1001
2025-1201
2026-0101
This device (reports/month)Average device in FMW (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Wellell Inc.

  • NAI 2015-02-04 Apex Medical (Kunshan) Corp. · 2 citations
  • VAI 2014-11-07 Wellell Inc · 0 citations
  • VAI 2014-11-07 Wellell Inc · 0 citations
  • VAI 2012-02-23 Wellell Inc · 2 citations
  • VAI 2012-02-23 Wellell Inc · 2 citations
  • NAI 2011-12-01 Apex Medical (Kunshan) Corp. · 0 citations