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Portable Electro-Stimulation Therapy Device
Model LGT-235(US) · Guangzhou Longest Medical Technology Co., Ltd. · DI 06976287180831
NUH — Stimulator, Nerve, Transcutaneous, Over-The-Counter · Class II · 21 CFR 882.5890
NYH — Plaque Disclosing Kit · Class II · 21 CFR 872.1740
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)
2019-07
0
10
2020-04
0
1
2020-05
0
1
2021-01
0
1
2021-03
0
1.5
2021-04
0
2
2022-07
0
2
2023-08
0
4
2023-09
0
4
2024-02
0
1
2024-05
0
4
2024-10
0
1
2024-11
0
3
2025-08
0
1
2025-12
0
1
2026-01
0
1
2026-02
0
1
2026-04
0
1
This device (reports/month)Average device in NUH, NYH (reports/device/month)