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APEX

Model "5"" One Piece Pad" · Wellell Inc. · DI 04713025002497

FNM — Mattress, Air Flotation, Alternating Pressure · Class II · 21 CFR 880.5550

UDILibrary device dossier · generated 2026-09-06 · 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.

13462019-01: 0 reports for this device; peer average 3/device2019-02: 0 reports for this device; peer average 1.5/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 3/device2019-07: 0 reports for this device; peer average 3.25/device2019-08: 0 reports for this device; peer average 1.67/device2019-10: 0 reports for this device; peer average 2/device2019-11: 0 reports for this device; peer average 3/device2019-12: 0 reports for this device; peer average 1.67/device2020-01: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 3/device2020-11: 0 reports for this device; peer average 1.25/device2021-03: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1.6/device2021-06: 0 reports for this device; peer average 5/device2021-07: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 1.5/device2022-04: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1.5/device2022-07: 0 reports for this device; peer average 1.2/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 1.25/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 2.5/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1.4/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1.67/device2023-06: 0 reports for this device; peer average 1.29/device2023-07: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1.4/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 1.2/device2023-12: 0 reports for this device; peer average 1.5/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1.6/device2024-04: 0 reports for this device; peer average 2.4/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1.75/device2024-08: 0 reports for this device; peer average 1/device2024-09: 0 reports for this device; peer average 1.33/device2024-10: 0 reports for this device; peer average 2.13/device2024-11: 0 reports for this device; peer average 2.2/device2024-12: 0 reports for this device; peer average 1.11/device2025-01: 0 reports for this device; peer average 1.78/device2025-02: 0 reports for this device; peer average 2.83/device2025-03: 0 reports for this device; peer average 1.17/device2025-04: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1.17/device2025-08: 0 reports for this device; peer average 4.25/device2025-09: 0 reports for this device; peer average 2.29/device2025-10: 0 reports for this device; peer average 2.86/device2025-11: 0 reports for this device; peer average 1.67/device2026-01: 0 reports for this device; peer average 1.5/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 2.67/device2026-04: 0 reports for this device; peer average 2.5/device2026-05: 0 reports for this device; peer average 5.5/device2026-06: 0 reports for this device; peer average 5.33/device010203040506070810111201020304060708091011030405060709020304060708091011120102030405060708091011120102030405060708091011120102030405060708091011010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0103
2019-0201.5
2019-0302
2019-0402
2019-0502
2019-0603
2019-0703.25
2019-0801.67
2019-1002
2019-1103
2019-1201.67
2020-0102
2020-0201
2020-0301
2020-0401
2020-0602
2020-0701
2020-0801
2020-0902
2020-1003
2020-1101.25
2021-0301
2021-0401
2021-0501.6
2021-0605
2021-0701
2021-0901
2022-0203
2022-0301.5
2022-0401
2022-0601.5
2022-0701.2
2022-0801
2022-0902
2022-1001.25
2022-1102
2022-1202.5
2023-0101
2023-0201.4
2023-0302
2023-0401
2023-0501.67
2023-0601.29
2023-0701
2023-0801
2023-0901.4
2023-1002
2023-1101.2
2023-1201.5
2024-0102
2024-0201
2024-0301.6
2024-0402.4
2024-0501
2024-0601
2024-0701.75
2024-0801
2024-0901.33
2024-1002.13
2024-1102.2
2024-1201.11
2025-0101.78
2025-0202.83
2025-0301.17
2025-0401.5
2025-0502
2025-0601
2025-0701.17
2025-0804.25
2025-0902.29
2025-1002.86
2025-1101.67
2026-0101.5
2026-0201
2026-0302.67
2026-0402.5
2026-0505.5
2026-0605.33
This device (reports/month)Average device in FNM (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