ECP PSK
Model P-ECP/TM · Chongqing PSK-Health Sci-Tech Development Co.,Ltd. · DI 06971379470012
DRN — Device, Counter-Pulsating, External · Class II · 21 CFR 870.5225
UDILibrary device dossier · generated 2026-09-13 · 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.
No dated reports to chart.
Regulatory clearances
- K130439 SESE 2013-12-12 (k number procode)
Predicate lineage
K130439 — cited as predicate by K190683, K191955
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Chongqing PSK-Health Sci-Tech Development Co.,Ltd.
Nothing in the loaded window.