Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

Anal Stim Probe

Model SA9571 · Thought Technology Ltd. · DI 07540191000401

HCC — Device, Biofeedback · Class II · 21 CFR 882.5050

KPI — Stimulator, Electrical, Non-Implantable, For Incontinence · Class II · 21 CFR 876.5320

UDILibrary device dossier · generated 2026-09-11 · 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.

23562019-03: 0 reports for this device; peer average 6/device2024-07: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device030702
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0306
2024-0701
2026-0201
This device (reports/month)Average device in HCC, KPI (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K053434 — cited as predicate by K110179, K201014, K201290, K202648

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

Manufacturer compliance record — Thought Technology Ltd.

  • NAI 2012-04-25 Thought Technology Ltd. · 0 citations
  • NAI 2012-04-25 Thought Technology Ltd. · 0 citations
  • NAI 2010-10-21 Thought Technology Ltd. · 0 citations
  • NAI 2010-10-21 Thought Technology Ltd. · 0 citations