← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS II

KPI — Stimulator, Electrical, Non-Implantable, For Incontinence

DEVICE CLASS
Class II
REGULATION
21 CFR 876.5320
MEDICAL SPECIALTY
Gastroenterology, Urology
REVIEW PANEL
GU
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
11
510(K)/PMA CLEARANCES
510k: 11
0
RECALL ENTRIES

Recent clearances

K260178Shenzhen Konmed Technology Co., Ltd. · 510k2026-06-18
K252601Hunan Accurate Bio-Medical Technology Co., Ltd. · 510k2026-05-14
K252552Shenzhen Changkun Technology Co., Ltd. · 510k2026-05-06
K252831Dolanvy (Suzhou) Medical Technology Co., Ltd. · 510k2026-04-28
K252334Pontemedag · 510k2026-04-17
K251760Well-Life Healthcare , Ltd. · 510k2026-02-12
K251026Trinity Medical Solutions · 510k2025-08-29
K243079Verity Medical , Ltd. · 510k2025-06-26

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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