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Nalu Medical, Inc.
1 federal recall on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Nalu Medical, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-07-10FDA-DeviceClass IINeurostimulation Kit (Ported, Dual 8, 40 cm), REF: 71005-US Peripheral Nerve Stimulation Kit (Ported, Dual 8, 40 cm), REF: 71019-US Components of the Nalu Spinal Cord Stimulation System.
Neurostimulation Systems have a manufacturing non-conformance that may reduce the efficiency of the radiofrequency signals between the Implantable Pulse Generator (IPG) and the Therapy Disc, causing the IPG to be non-functional, which causes the device to be non-functional so it will no longer inhibit the transmission of pain signals to the brain.
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