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MyOnyx

Model SA9020 · Thought Technology Ltd. · DI 07540191000593

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

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

IPF — Stimulator, Muscle, Powered · Class II · 21 CFR 890.5850

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

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/device2019-03: 0 reports for this device; peer average 6/device2019-06: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1.33/device2019-11: 0 reports for this device; peer average 4/device2019-12: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1.5/device2020-03: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 2/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1/device2020-12: 0 reports for this device; peer average 1.5/device2022-01: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 2/device2022-10: 0 reports for this device; peer average 2/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/device2023-09: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 3.5/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1.5/device2024-07: 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/device2025-06: 0 reports for this device; peer average 1/device2025-12: 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/device02030610111202030607091011120106100405080903040506070810020304050612010206
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0306
2019-0602
2019-1001.33
2019-1104
2019-1202
2020-0201.5
2020-0302
2020-0602
2020-0702
2020-0902
2020-1001
2020-1101
2020-1201.5
2022-0102
2022-0602
2022-1002
2023-0401
2023-0501
2023-0801
2023-0901
2024-0303.5
2024-0402
2024-0501
2024-0601.5
2024-0701
2024-0802
2024-1001
2025-0201
2025-0301
2025-0401
2025-0502
2025-0601
2025-1202
2026-0108
2026-0201
2026-0601
This device (reports/month)Average device in GZJ, HCC, IPF, KPI (reports/device/month)

Regulatory clearances

  • K213197 SESE 2022-06-17 (k number procode)
  • K201014 SESE 2021-01-13 (k number procode)

Predicate lineage

K201014 — cites (transitively): K023906 (d1), K053434 (d1), K122194 (d1), K934552 (d1), K971541 (d2), K990456 (d2) — cited as predicate by K213043, K213197, K230767

K213197 — cites (transitively): K132422 (d1), K171978 (d1), K201014 (d1), K083302 (d2), K130987 (d2), K874469 (d2), K071137 (d2), K093138 (d2), K023906 (d2), K053434 (d2), K122194 (d2), K934552 (d2), K070612 (d3), K971541 (d3), K990456 (d3), K970426 (d3)

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