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1 YEAR TIMED CHAIR PAD,SIX PACK

Model 96160 · Securitas Healthcare LLC · DI 00840948101823

KMI — Monitor, Bed Patient · Class I · 21 CFR 880.2400

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.

12342019-01: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 4/device2020-06: 0 reports for this device; peer average 2/device2020-08: 0 reports for this device; peer average 1/device2020-10: 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 2/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 2/device2021-12: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 1.33/device2022-06: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1.33/device2022-09: 0 reports for this device; peer average 4/device2022-10: 0 reports for this device; peer average 1.33/device2022-12: 0 reports for this device; peer average 1.5/device2023-01: 0 reports for this device; peer average 2/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1.5/device2023-08: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 1.67/device2023-12: 0 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1.25/device2024-02: 0 reports for this device; peer average 1.5/device2024-03: 0 reports for this device; peer average 1.4/device2024-04: 0 reports for this device; peer average 1.2/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 3.2/device2024-08: 0 reports for this device; peer average 1.4/device2024-09: 0 reports for this device; peer average 1.33/device2024-10: 0 reports for this device; peer average 1.67/device2024-11: 0 reports for this device; peer average 2.25/device2024-12: 0 reports for this device; peer average 1.67/device2025-01: 0 reports for this device; peer average 1.8/device2025-02: 0 reports for this device; peer average 2/device2025-03: 0 reports for this device; peer average 1.5/device2025-04: 0 reports for this device; peer average 1.67/device2025-05: 0 reports for this device; peer average 1.75/device2025-06: 0 reports for this device; peer average 2.2/device2025-07: 0 reports for this device; peer average 1/device2025-08: 0 reports for this device; peer average 1/device2025-09: 0 reports for this device; peer average 1.5/device2025-10: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 1.33/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 1.5/device2026-04: 0 reports for this device; peer average 1.6/device2026-05: 0 reports for this device; peer average 4/device2026-06: 0 reports for this device; peer average 2.67/device01030508030608100607080910111201030608091012010203040508101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0302
2019-0501
2019-0802
2020-0304
2020-0602
2020-0801
2020-1001
2021-0602
2021-0702
2021-0802
2021-0902
2021-1002
2021-1102
2021-1201
2022-0102
2022-0301.33
2022-0601
2022-0801.33
2022-0904
2022-1001.33
2022-1201.5
2023-0102
2023-0202
2023-0301
2023-0401
2023-0501.5
2023-0801
2023-1002
2023-1101.67
2023-1201
2024-0101.25
2024-0201.5
2024-0301.4
2024-0401.2
2024-0501
2024-0601
2024-0703.2
2024-0801.4
2024-0901.33
2024-1001.67
2024-1102.25
2024-1201.67
2025-0101.8
2025-0202
2025-0301.5
2025-0401.67
2025-0501.75
2025-0602.2
2025-0701
2025-0801
2025-0901.5
2025-1002
2025-1101
2025-1202
2026-0101.33
2026-0202
2026-0301.5
2026-0401.6
2026-0504
2026-0602.67
This device (reports/month)Average device in KMI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Securitas Healthcare LLC

  • VAI 2023-06-22 Securitas Healthcare LLC · 1 citations
  • VAI 2023-06-22 Securitas Healthcare LLC · 1 citations
  • NAI 2017-02-06 Securitas Healthcare LLC · 0 citations
  • NAI 2017-02-06 Securitas Healthcare LLC · 0 citations
  • VAI 2013-11-08 Securitas Healthcare LLC · 1 citations
  • VAI 2013-11-08 Securitas Healthcare LLC · 1 citations
  • NAI 2011-01-11 Securitas Healthcare LLC · 0 citations
  • NAI 2011-01-11 Securitas Healthcare LLC · 0 citations
  • VAI 2010-08-25 Securitas Healthcare LLC · 0 citations
  • VAI 2010-08-25 Securitas Healthcare LLC · 0 citations