RenewTM NCP-5 External Counterpulsation System
Model NCP-5 · RENEW GROUP PRIVATE LIMITED · DI 08883000001640
DRN — Device, Counter-Pulsating, External · Class II · 21 CFR 870.5225
UDILibrary device dossier · generated 2026-09-15 · 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
- K152115 SESE 2015-12-17 (k number procode)
Predicate lineage
K152115 — cites (transitively): K042413 (d1) — cited as predicate by K173483, K250756
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — RENEW GROUP PRIVATE LIMITED
Nothing in the loaded window.