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Bio Protech

Model MaxIF 1k Unit · BIO PROTECH USA, INC. · DI 00817120020579

LIH — Interferential Current Therapy · Class II · 21 CFR 882.5890

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.

24682019-02: 0 reports for this device; peer average 1/device2019-10: 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 3/device2024-05: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 8/device02100804050201
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
2023-0801
2024-0403
2024-0501
2025-0201
2026-0108
This device (reports/month)Average device in LIH (reports/device/month)

Regulatory clearances

  • K100246 SESE 2010-11-24 (k number procode)

Manufacturer compliance record — BIO PROTECH USA, INC.

  • OAI 2025-03-13 Bio Protech Yantai Inc. · 5 citations
  • VAI 2020-02-20 Bio Protech Usa, Inc. · 4 citations
  • NAI 2016-03-25 Bio Protech Yantai Inc. · 0 citations
  • NAI 2016-03-23 Bio Protech, Inc. · 0 citations
  • NAI 2016-03-23 Bio Protech, Inc. · 0 citations
  • VAI 2014-02-26 Bio Protech Usa, Inc. · 0 citations
  • VAI 2011-08-31 Bio Protech Usa, Inc. · 1 citations
  • VAI 2010-12-09 Bio Protech, Inc. · 6 citations
  • VAI 2010-12-09 Bio Protech, Inc. · 6 citations