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SCS: This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device. PNS: This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The Nalu Neurostimulation System for PNS is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Neurostimulation System (referred to as the "Nalu System") incorporates a miniature implantable pulse generator (IPG), powered by an externally worn Therapy Disc device. The Nalu System therapy utilizes pulsed electrical current to create an energy field that acts on peripheral nerves or central nerves to inhibit the transmission of pain signals to the brain. The Nalu System may be implanted following a successful trial period using the Nalu Neurostimulation trial system. This device is intended to be used in the spinal column as well as the peripheral nerves in arm, leg, pelvic and other areas, as is typical of other devices and treatments for the same intended use. The Nalu System is intended for stimulation of the spinal cord or peripheral nerves for patients experiencing chronic, intractable pain. This system is indicated for pain management in adults who have severe intractable chronic pain, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device. The Nalu System is comprised of the following components: • Implantables (there are no proposed changes to these components as previously provided in K221376): o Implantable pulse generator (IPG; available either as an integrated lead unit or with separately connected lead(s)) – provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site(s). o Leads – implantable and designed to deliver electrical pulses to the nerves via an array of four (4) or eight (8) cylindrical electrodes at the distal end. o Surgical and Trial Tools – includes anchors, spoonbill needs, stylets, tearaway introducers, pocket tunneler, torque wrench, IPG insertion tool, straw tunneler; tools to support implantation of lead and IPG. - Externals, Non-Sterile: o Externally worn controllers (for use with the permanent implant) and accessories – includes the Therapy Disc, Adhesive Clip, Wearable Garment, Therapy Disc Charger; houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer (subject of this submission). o Externally worn stimulator (for use with the trial lead) and accessories – includes the Trial Therapy Disc; sends signals to the percutaneous leads during the trial period by way of the Electrode Interface Cable (EIC). • Software (subject of this submission): o Clinician Programmer, Patient Remote Control – used to configure the system parameters; also manages patient records, Therapy Discs and remote controls for patients with the Nalu System; runs on Android and iOS platforms and can be optionally used to control and manage Therapy Discs over a secure Bluetooth® Low Energy connection.

Spinal Cord Stimulation (SCS) This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device. Peripheral Nerve Stimulation (PNS) This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation (SCS; K203547) and peripheral nerve stimulation (PNS; K203547) to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral, bilateral nerve pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord or peripheral nerve to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system. The Nalu Neurostimulation System consists of five (5) components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site. The leads are implantable and designed to deliver electrical pulses to the nerves via an array of four (4) or eight (8) cylindrical electrodes at the distal end. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for Spinal Cord Stimulation (SCS) or Peripheral Nerve Stimulation (PNS) is performed via standard surgical tools and techniques, as described in (K203547).

For Spinal Cord Stimulation: This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device. For Peripheral Nerve Stimulation: This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 day) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Neurostimulation System has been cleared by the FDA for spinal cord stimulation, and peripheral nerve stimulation (K201618), to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral, bilateral nerve pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord or peripheral nerve to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system. The Nalu Neurostimulation System consists of several components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site. The leads are implantable and designed to deliver electrical pulses to the nerves via an array of four or eight cylindrical electrodes at the distal end. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for spinal cord stimulation (SCS) or peripheral nerve stimulation (PNS) is performed via standard surgical tools and techniques, as described in (K201618).

For Spinal Cord Stimulation This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Neurostimulation system is consisted of five components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, through the dura, to the desired location of the spinal cord site. The leads are implantable and designed to deliver electrical pulses to the spinal cord in the epidural space via an array of eight cylindrical electrodes at the distal end. The leads may be secured in place with the Nalu Lead Anchor. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for Spinal Cord Stimulation (SCS) is performed via standard SCS surgical tools and techniques, as described in (K183047).

Spinal Cord Stimulation (SCS) This system is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device. Peripheral Nerve Stimulation (PNS) This system is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach. The system is not intended to treat pain in the craniofacial region. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Neurostimulation system has been cleared by the FDA for spinal cord stimulation (SCS; K183047) and peripheral nerve stimulation (PNS; K183579, and K191435) to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral, bilateral nerve pain. The Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord or peripheral nerve to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system. The Nalu Neurostimulation system consists of five components. The implantable pulse generator (IPG) provides electrical stimulation pulses that are transmitted through the leads, to the desired location, either on the spinal cord or peripheral nerve site. The leads are implantable and designed to deliver electrical pulses to the nerves via an array of four or eight cylindrical electrodes at the distal end. The Trial Therapy Disc or the Therapy Disc houses the battery and electronics for RF power and controls the IPG for therapy delivery via the remote programmer. Implantation of the Nalu IPG and lead components for Spinal Cord Stimulation (SCS) or Peripheral Nerve Stimulation (PNS) is performed via standard surgical tools and techniques, as described in (K183047, K183579, and K191435).

The SandShark Injectable Anchor (SIA) System is intended to be an accessory to the stimulator component of the Stimwave Freedom Spinal Cord Stimulator (SCS) System to secure the fascia or interspinous/supraspinous ligament.

The Stimwave Technologies Incorporated (Stimwave) SandShark Injectable Anchor (SIA) System is used to fixate the Stimwave Freedom Stimulator to surrounding tissue. The System is comprised of a carbothane anchor (SandShark Anchor) that is transferred onto the deployment handle (SandShark Injectroducer) with the Loading Rod and Loading Base. The SIA System is provided sterile. The SandShark Injectroducer is used to deploy the SandShark Anchor onto the Stimulator.

The Nalu Neurostimulation System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (no longer thank 30 days) to determine efficacy before recommendation for a permanent (long term) device. The Nalu Lead Blank is an optional accessory intended to be used as a surgical aide to insert the Nalu Neurostimulation System Leads.

The Nalu Lead Blank is an optional accessory to the Nalu Neurostimulation System (also referred to as the "Nalu System"), which is used for spinal cord stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain. The Nalu Neurostimulation System incorporates a miniature implanted neurostimulator, powered by an externally worn device. The Nalu Lead Blank is an optional non-implantable surgical tool used during implant of the Nalu Neurostimulation System leads. The Nalu Lead Blank may be used to create a path for the lead in the epidural space.

The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. The Freedom-8A Trial Lead Kit is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and the Freedom-4A Trial Lead Kit is used for either the Receiver Kit Freedom-4A or the Receiver Kit Freedom-8A Stimulator. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Stimwave Technologies Incorporated (Stimwave) Freedom Spinal Cord SCS System (System) is used for spinal column stimulation to provide therapeutic relief for chronic. intractable pain of the trunk and and/or lower limbs including unilateral or bilateral pain. The therapy utilizes pulsed electrical current to create an energy field that acts on nerves near the spinal column. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator), receiver component (Receiver), and an externally worn transmitter (Wearable Antenna Assembly (WAA)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.

The Nalu Neurostimulation System is indicated as the sole mitigating agent or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain. The trial devices are solely used for trial stimulation (no longer thank 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Nalu Neurostimulation system (also referred to as the "Nalu System") is used for spinal cord stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain. The Nalu Neurostimulation system incorporates a miniature implanted neurostimulator, powered by an externally worn device. Similar to the predicate Stimwave system, the Nalu Neurostimulation therapy utilizes pulsed electrical current to create an energy field that acts on nerves in the spinal cord to inhibit the transmission of pain signals to the brain. The Nalu System is implanted only following a successful trial period using the Nalu Neurostimulation trial system. The Nalu Neurostimulation System is comprised of 5 elements: Nalu Implantable Pulse Generator, Leads, Surgical and Trial Tools, Externally worn Therapy Discs, and Programmer, Remote.

The Freedom Spinal Cord Stimulator (SCS) System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. The Freedom-8A Trial Lead Kit is only used in conjunction with the Freedom-8A Stimulator Receiver Kit, and the Freedom-4A Trial Lead Kit is used for either the Receiver Kit Freedom-4A Stimulator or the Receiver Kit Freedom-8A Stimulator. The trial devices are solely used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) device.

The Stimwave Technologies Incorporated (Stimwave) Freedom Spinal Cord SCS System (System) is used for spinal column stimulation to provide therapeutic relief for chronic, intractable pain of the trunk and/or lower limbs including unilateral pain. The therapy utilizes pulsed electrical current to create an energy field that acts on nerves near the spinal column. The System is comprised of an implantable stimulator (Freedom-8A/4A Stimulator), receiver component (Receiver), and an externally worn transmitter (Wearable Antenna Assembly (WAA)) to power the device. The System is implanted only following a successful trial period with the Freedom-8A/4A Trial Lead.