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OpiEase
NEUROSTIMULATION MEDTECH PRIVATE LIMITED · Model OpiEase · UDI-DI 08908006064205
PZR
Prescription
8
510(k) clearances
0
Adverse events
1
Recalls
6
Facilities
Description
OpiEase
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-07-02 | Spark Biomedical Inc | Due to manufacturing issue, neurostimulator device may experience "cable disconnect" error message and interruption to stimulation output. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.