FDA-Device2024-07-10Class II
Neurostimulation 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.
Nalu Medical, Inc.
Hazard
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.
Sold states
US Nationwide distribution in the states of MO, IL, CA, TX, TN, OK, AZ, AR.
Affected count
13
Manufactured in
2320 Faraday Ave Ste 100, N/A, Carlsbad, CA, United States
Products
Neurostimulation 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2257-2024Don't want to check this manually?
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