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InTENSity

Model DI4738 · Drive Devilbiss Healthcare · DI 00092237616680

GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief · Class II · 21 CFR 882.5890

UDILibrary device dossier · generated 2026-09-14 · 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.

24682019-02: 0 reports for this device; peer average 1/device2019-10: 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 3/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1.5/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 1/device2023-08: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 2/device2024-10: 0 reports for this device; peer average 1/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 2/device2026-01: 0 reports for this device; peer average 8/device2026-02: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 1/device0210020311120405080405081002030405010206
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-1001
2020-0201
2020-0303
2020-1101
2020-1201.5
2023-0401
2023-0501
2023-0801
2024-0402
2024-0501
2024-0802
2024-1001
2025-0201
2025-0301
2025-0401
2025-0502
2026-0108
2026-0201
2026-0601
This device (reports/month)Average device in GZJ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K093138 — cites (transitively): K070612 (d1), K071137 (d1) — cited as predicate by K113010, K120054, K171978

Lineage extracted from public 510(k) summary text (heuristic).

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