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4 chamber sleeve

Model MXW401 · DAESUNG MAREF CO.,LTD. · DI 08809802640559

IRP — Massager, Powered Inflatable Tube · Class II · 21 CFR 890.5650

UDILibrary device dossier · generated 2026-09-11 · 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.

23562019-08: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 2/device2021-07: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 4/device2025-01: 0 reports for this device; peer average 6/device2025-07: 0 reports for this device; peer average 1.5/device080406070105110107
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0801
2021-0401
2021-0602
2021-0701
2023-0102
2024-0502
2024-1104
2025-0106
2025-0701.5
This device (reports/month)Average device in IRP (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K150033 — cites (transitively): K102320 (d1), K013331 (d2), K100656 (d2), K080134 (d3) — cited as predicate by K231437

K203019 — cites (transitively): K113275 (d1) — cited as predicate by K231437

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — DAESUNG MAREF CO.,LTD.

  • NAI 2018-07-26 Daesung Maref Co., Ltd. · 0 citations
  • NAI 2018-07-26 Daesung Maref Co., Ltd. · 0 citations
  • VAI 2015-06-04 Daesung Maref Co., Ltd. · 0 citations
  • VAI 2015-06-04 Daesung Maref Co., Ltd. · 0 citations