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Alpha-Stim

Model 18-50-155614 · PARKER LABORATORIES INC · DI 10855683006880

GYB — Media, Electroconductive · Class II · 21 CFR 882.1275

UDILibrary device dossier · generated 2026-09-15 · 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.

11222019-11: 0 reports for this device; peer average 2/device2021-01: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 1/device2023-10: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 2/device110103121006
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1102
2021-0102
2021-0302
2022-1201
2023-1002
2025-0602
This device (reports/month)Average device in GYB (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — PARKER LABORATORIES INC

  • VAI 2023-05-23 Parker Laboratories, Inc. · 4 citations
  • VAI 2023-05-23 Parker Laboratories, Inc. · 4 citations
  • VAI 2018-03-20 Parker Laboratories, Inc. · 3 citations
  • VAI 2018-03-20 Parker Laboratories, Inc. · 3 citations
  • VAI 2014-10-15 Parker Laboratories, Inc. · 2 citations
  • VAI 2014-10-15 Parker Laboratories, Inc. · 2 citations
  • NAI 2011-05-19 Parker Laboratories, Inc. · 0 citations
  • NAI 2011-05-19 Parker Laboratories, Inc. · 0 citations