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Model 700-940 · Drive Devilbiss Healthcare · DI 07540212131534

ITJ — Walker, Mechanical · Class I · 21 CFR 890.3825

UDILibrary device dossier · generated 2026-09-13 · 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.

11222019-01: 0 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1.14/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1.25/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1.5/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2020-06: 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 1/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1/device2021-02: 0 reports for this device; peer average 1/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/device2021-06: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1/device2021-10: 0 reports for this device; peer average 1/device2021-11: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1.13/device2022-04: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1.09/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1.21/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1.17/device2023-05: 0 reports for this device; peer average 1.1/device2023-06: 0 reports for this device; peer average 1/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/device2023-10: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 1.2/device2023-12: 0 reports for this device; peer average 1.25/device2024-01: 0 reports for this device; peer average 2/device2024-03: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1.5/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 1.4/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 1/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/device2025-10: 0 reports for this device; peer average 1.33/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/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1.75/device2026-04: 0 reports for this device; peer average 1.67/device2026-05: 0 reports for this device; peer average 1.33/device2026-06: 0 reports for this device; peer average 1/device0102030405070809101112010203040506080910111202030405060708091011120304070809101112010203040506070809101112010304050607081011120102030405070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101
2019-0201
2019-0301
2019-0401
2019-0501
2019-0701.14
2019-0801
2019-0901
2019-1001
2019-1101
2019-1201.25
2020-0101
2020-0201
2020-0301.5
2020-0401
2020-0501
2020-0601
2020-0801
2020-0901
2020-1001
2020-1101
2020-1201
2021-0201
2021-0301
2021-0401
2021-0501
2021-0601
2021-0701
2021-0801
2021-0901
2021-1001
2021-1101
2021-1201
2022-0301.13
2022-0401
2022-0701.09
2022-0801
2022-0901.21
2022-1001
2022-1101
2022-1201
2023-0101
2023-0201
2023-0301
2023-0401.17
2023-0501.1
2023-0601
2023-0701
2023-0801
2023-0901
2023-1001
2023-1101.2
2023-1201.25
2024-0102
2024-0301
2024-0401
2024-0501.5
2024-0601
2024-0701
2024-0801
2024-1001
2024-1101
2024-1201
2025-0101.4
2025-0201
2025-0301
2025-0401
2025-0501
2025-0701
2025-0801
2025-0901
2025-1001.33
2025-1101
2025-1202
2026-0101
2026-0201
2026-0301.75
2026-0401.67
2026-0501.33
2026-0601
This device (reports/month)Average device in ITJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Drive Devilbiss Healthcare

  • Warning Letter 2021-11-23 DeVilbiss Healthcare LLC
  • Warning Letter 2012-10-10 Drive DeVilbiss Healthcare
  • NAI 2024-05-30 DeVilbiss Healthcare LLC · 0 citations
  • OAI 2022-08-17 DeVilbiss Healthcare LLC · 4 citations
  • OAI 2021-08-25 DeVilbiss Healthcare LLC · 9 citations
  • VAI 2016-02-24 Drive DeVilbiss Healthcare · 0 citations
  • NAI 2016-01-28 DeVilbiss Healthcare LLC · 0 citations
  • VAI 2014-07-18 Drive DeVilbiss Healthcare · 3 citations
  • OAI 2012-08-31 Drive DeVilbiss Healthcare · 8 citations
  • NAI 2012-02-22 DeVilbiss Healthcare LLC · 0 citations
  • NAI 2010-03-31 DeVilbiss Healthcare LLC · 0 citations