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Biowave Noninvasive Electrodes

Model MK78580 - BWEN03-U · BIOWAVE CORPORATION · DI 00859911006102

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

LIH — Interferential Current Therapy · 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 2.33/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
2024-0402.33
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, LIH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — BIOWAVE CORPORATION

  • VAI 2026-05-26 Biowave Corporation · 3 citations
  • VAI 2026-05-26 Biowave Corporation · 3 citations
  • VAI 2023-06-21 Biowave Corporation · 4 citations
  • VAI 2023-06-21 Biowave Corporation · 4 citations
  • VAI 2017-04-27 Biowave Corporation · 2 citations
  • VAI 2017-04-27 Biowave Corporation · 2 citations
  • VAI 2013-08-28 Biowave Corporation · 6 citations
  • VAI 2013-08-28 Biowave Corporation · 6 citations
  • NAI 2011-02-18 Biowave Corporation · 0 citations
  • NAI 2011-02-18 Biowave Corporation · 0 citations
  • VAI 2010-07-28 Biowave Corporation · 2 citations
  • VAI 2010-07-28 Biowave Corporation · 2 citations