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AB FLEX

Model MC0413 · · DI 06972946644133

NGX — Stimulator, Muscle, Powered, For Muscle Conditioning · Class II · 21 CFR 890.5850

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.

23562019-11: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 6/device2021-01: 0 reports for this device; peer average 1.13/device2022-02: 0 reports for this device; peer average 6/device2022-07: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2022-12: 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/device2023-09: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 3/device2025-03: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 1/device2025-07: 0 reports for this device; peer average 1.5/device2025-08: 0 reports for this device; peer average 2.5/device2025-09: 0 reports for this device; peer average 1/device2025-10: 0 reports for this device; peer average 3.5/device2025-11: 0 reports for this device; peer average 4.67/device2025-12: 0 reports for this device; peer average 1.54/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 4/device2026-04: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 4/device1103040102071012040509020303060708091011120102030406
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1102
2020-0303
2020-0406
2021-0101.13
2022-0206
2022-0701
2022-1001
2022-1202
2023-0401
2023-0501
2023-0902
2024-0201
2024-0303
2025-0302
2025-0601
2025-0701.5
2025-0802.5
2025-0901
2025-1003.5
2025-1104.67
2025-1201.54
2026-0101
2026-0201
2026-0304
2026-0401
2026-0604
This device (reports/month)Average device in NGX (reports/device/month)

Regulatory clearances

  • K183103 SESE 2019-09-18 (k number procode)

Predicate lineage

K183103 — cites (transitively): K133929 (d1), K143207 (d1), K143430 (d1), K171803 (d1), K121719 (d2), K122744 (d2), K123354 (d2), K132588 (d2), K133965 (d2), K120398 (d2), K140168 (d2), K130802 (d2), K150386 (d2), K061516 (d3), K061650 (d3), K060846 (d3), K102598 (d3), K112392 (d3), K070612 (d3), K040253 (d3), K110068 (d3), K132993 (d3), K040512 (d4)

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

Manufacturer compliance record — n/a

Nothing in the loaded window.