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DLR

Model DLR-8921 · Dolanvy (Suzhou) Medical Technology Co.,Ltd. · DI 06975854030029

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

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)

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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)
2026-02	0	1

This device (reports/month)Average device in KPI (reports/device/month)

Regulatory clearances

K252831 SESE 2026-04-28 (k number procode)

Manufacturer compliance record — Dolanvy (Suzhou) Medical Technology Co.,Ltd.

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