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4 chamber extension zipper

Model 4ECGF01 · DAESUNG MAREF CO.,LTD. · DI 08809802640665

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

K202395 — cites (transitively): K182668 (d1), K030437 (d2), K160608 (d2), K161907 (d2), K112154 (d3), K112890 (d3), K122154 (d3), K113275 (d3), K000655 (d4), K032505 (d4), K071596 (d4), K092435 (d4), K040905 (d5)

K203498 — cites (transitively): K182668 (d1), K203552 (d1), K030437 (d2), K160608 (d2), K161907 (d2), K183169 (d2), K112154 (d3), K112890 (d3), K122154 (d3), K113275 (d3), K000655 (d4), K032505 (d4), K071596 (d4), K092435 (d4), K040905 (d5)

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