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Applicator 9202
Model 9202 · METTLER ELECTRONICS CORP. · DI 00816864020654
GZI — Stimulator, Neuromuscular, External Functional · Class II · 21 CFR 882.5810
GZJ — Stimulator, Nerve, Transcutaneous, For Pain Relief · Class II · 21 CFR 882.5890
IMG — Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat · Class II · 21 CFR 890.5860
IPF — Stimulator, Muscle, Powered · Class II · 21 CFR 890.5850
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.
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-02
0
1
2019-04
0
2
2019-06
0
2.67
2019-07
0
2
2019-08
0
2
2019-09
0
2
2019-10
0
1.33
2019-11
0
4
2019-12
0
1.75
2020-02
0
1.67
2020-03
0
2
2020-06
0
2
2020-07
0
1.5
2020-09
0
2
2020-10
0
1
2020-11
0
1
2020-12
0
1.5
2021-02
0
1
2021-03
0
2
2021-04
0
2
2021-10
0
2
2021-12
0
2
2022-01
0
2
2022-02
0
2
2022-03
0
2.8
2022-05
0
2
2022-06
0
2
2022-08
0
2
2022-09
0
2
2022-10
0
2
2022-11
0
1
2022-12
0
2
2023-01
0
2
2023-02
0
2
2023-04
0
1
2023-05
0
1
2023-06
0
2
2023-07
0
2
2023-08
0
1
2023-09
0
1
2024-03
0
3.5
2024-04
0
2
2024-05
0
2.5
2024-06
0
1.67
2024-08
0
2
2024-10
0
1
2025-02
0
1.33
2025-03
0
1
2025-04
0
1
2025-05
0
2
2025-06
0
1
2025-08
0
1
2025-09
0
1
2025-12
0
1.5
2026-01
0
8
2026-02
0
1
2026-05
0
1
2026-06
0
1
This device (reports/month)Average device in GZI, GZJ, IMG, IPF (reports/device/month)
Regulatory clearances
K111482 SESE 2011-08-25 (k number procode)
Predicate lineage
K111482 — cites (transitively): K071137 (d1) — cited as predicate by K182108
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — METTLER ELECTRONICS CORP.
VAI 2026-03-06 Mettler Electronics Corp · 2 citations
VAI 2026-03-06 Mettler Electronics Corp · 2 citations
VAI 2023-09-14 Mettler Electronics Corp · 4 citations
VAI 2023-09-14 Mettler Electronics Corp · 4 citations
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