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Nalu Medical, Inc.

NALU MEDICAL, INC. · Model 34004-US · UDI-DI 00812537030265

GZFGZB Prescription
10
510(k) clearances
4,507
Adverse events (16 deaths)
7
Recalls
27
Facilities

Description

Electrode Interfacing Cable (EIC) (68.58 cm) is an electrical connector that mates with the proximal end of the Lead or the Lead extension external to the patient and connects with a Trial Therapy Disc (or the EIC Extension which likewise connects to the Trial Therapy Disc to provide an extension bridging the sterile field).

Recalls

DateFirmReason
2024-06-03Nalu 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
2020-07-15Stimwave Technologies IncThe product contains a non-functional component not referenced in product labeling.
2020-07-15Stimwave Technologies IncThe product contains a non-functional component not referenced in product labeling.
2020-07-15Stimwave Technologies IncThe product contains a non-functional component not referenced in product labeling.
2020-07-15Stimwave Technologies IncThe product contains a non-functional component not referenced in product labeling.
2020-07-15Stimwave Technologies IncThe product contains a non-functional component not referenced in product labeling.
2020-07-15Stimwave Technologies IncThe 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.