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AIR JUNIOR AIR PUMP AND CUSHION SYSTEM

WELLELL INC.

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.

No dated reports to chart.

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