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Applicator 7513

Model 7513 · METTLER ELECTRONICS CORP. · DI 00816864020630

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

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

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

UDILibrary device dossier · generated 2026-09-12 · 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/device2019-06: 0 reports for this device; peer average 2/device2019-10: 0 reports for this device; peer average 1.25/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 2.33/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1.5/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/device0206101112020306070910111201061004050809030405060810020304050612010206
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0201
2019-0602
2019-1001.25
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
2024-0402.33
2024-0501
2024-0601.5
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, IPF, LIH (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K984142 — cited as predicate by K113017

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

Manufacturer compliance record — METTLER ELECTRONICS CORP.

  • VAI 2026-03-06 Mettler Electronics Corp · 2 citations
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  • VAI 2023-09-14 Mettler Electronics Corp · 4 citations
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  • NAI 2015-08-28 Mettler Electronics Corp · 0 citations
  • NAI 2015-08-28 Mettler Electronics Corp · 0 citations
  • VAI 2010-08-03 Mettler Electronics Corp · 1 citations
  • VAI 2010-08-03 Mettler Electronics Corp · 1 citations