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StimRouter User Kit

BIONESS INC. · Model ST2-5050 · UDI-DI 00815962021464

GZF Prescription

510(k) clearances

4,615

Adverse events (17 deaths)

Recalls

Facilities

Description

External Electrical Field Conductor

Recalls

Date	Firm	Reason
2024-06-03	Nalu Medical, Inc.	Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the The
2020-07-15	Stimwave Technologies Inc	The product contains a non-functional component not referenced in product labeling.
2020-07-15	Stimwave Technologies Inc	The product contains a non-functional component not referenced in product labeling.
2020-07-15	Stimwave Technologies Inc	The product contains a non-functional component not referenced in product labeling.
2020-07-15	Stimwave Technologies Inc	The product contains a non-functional component not referenced in product labeling.
2020-07-15	Stimwave Technologies Inc	The product contains a non-functional component not referenced in product labeling.
2020-07-15	Stimwave Technologies Inc	The product contains a non-functional component not referenced in product labeling.

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Data 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.