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Arjo Sling
Model MAA2040M-LL · Arjohuntleigh AB · DI 05056097360126
FSA — Lift, Patient, Non-Ac-Powered · Class I · 21 CFR 880.5510
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 (2)
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.
Injury: 2
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
1
2019-02
0
1
2019-03
0
7.2
2019-04
0
1
2019-05
0
2
2019-06
0
1.17
2019-07
0
1.33
2019-08
0
1
2019-09
0
1
2019-10
0
1
2019-11
0
1.5
2019-12
0
1
2020-02
0
1
2020-03
0
1.2
2020-04
0
1.2
2020-05
0
1.5
2020-06
0
1
2020-07
0
1
2020-08
0
1
2020-09
0
1
2020-10
0
1.2
2020-11
0
1.4
2020-12
0
1
2021-01
0
1
2021-02
0
1.67
2021-03
0
1.5
2021-04
0
1
2021-05
0
1.14
2021-06
0
1.67
2021-07
0
2
2021-08
0
2
2021-09
0
2.5
2021-10
0
1
2021-11
0
1
2021-12
0
1
2022-01
0
2
2022-02
0
1.33
2022-03
0
1.5
2022-04
2
1.17
2022-05
0
1.57
2022-06
0
1.43
2022-07
0
1
2022-08
0
1.75
2022-09
0
1
2022-10
0
1.67
2022-11
0
1
2022-12
0
1.25
2023-01
0
2
2023-02
0
1.2
2023-03
0
1.4
2023-04
0
1.57
2023-05
0
1.75
2023-06
0
1.4
2023-07
0
3
2023-08
0
1.5
2023-09
0
1.33
2023-10
0
2
2023-11
0
1.6
2023-12
0
1.18
2024-01
0
1.4
2024-02
0
1.6
2024-03
0
1.8
2024-04
0
1.5
2024-05
0
1.38
2024-06
0
1
2024-07
0
1.38
2024-08
0
1.67
2024-09
0
1.67
2024-10
0
1.7
2024-11
0
1.75
2024-12
0
1.83
2025-01
0
1.82
2025-02
0
2
2025-03
0
1.28
2025-04
0
1.63
2025-05
0
1.27
2025-06
0
1.13
2025-07
0
1.13
2025-08
0
1.5
2025-09
0
1.5
2025-10
0
1.33
2025-11
0
1.5
2025-12
0
1.5
2026-01
0
1.47
2026-02
0
1.45
2026-03
0
1.5
2026-04
0
1.65
2026-05
0
2.27
2026-06
0
1.89
This device (reports/month)Average device in FSA (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Arjohuntleigh AB
NAI 2015-04-23 Arjo (Suzhou) Co., Ltd. · 0 citations
VAI 2014-03-20 ARJOHUNTLEIGH POLSKA Sp. z.o.o. · 3 citations
NAI 2013-02-07 ARJOHUNTLEIGH AB · 0 citations
NAI 2013-02-07 ARJOHUNTLEIGH AB · 0 citations
VAI 2012-09-06 Huntleigh Healthcare Ltd. · 0 citations
NAI 2011-11-24 Arjo (Suzhou) Co., Ltd. · 0 citations