FDA-cleared miniature peripheral nerve stimulator powered by a worn Therapy Disc, cleared 2019 with later 510(k)s through 2024. Thin: 510(k) text only.
Independent, source-linked catalog sheet. Not a manufacturer-issued datasheet, regulatory decision or instructions for clinical use. Human evidence does not establish approval. Source-specific restrictions, conflicts and missing specifications are retained below.
Nalu neurostimulation system PNS
The Nalu system is a miniature implanted peripheral nerve stimulator with an eight-electrode lead, powered wirelessly by a worn Therapy Disc. This sheet uses the 2019 510(k) K183579 and the 2024 K232415 record. A 510(k) shows substantial equivalence, not efficacy.
Identity
Field
Value and source scope
Device
Nalu Neurostimulation System for Peripheral Nerve Stimulation: miniature implanted pulse generator, leads, externally worn Therapy Disc, trial system, clinician programmer and patient remote [1]
Manufacturer
Nalu Medical, Inc., Carlsbad, California [1]
Interface class
Wirelessly powered implanted peripheral nerve stimulator with lead electrodes [1]
Origin
Commercial FDA-cleared device; 510(k) K183579 [1]
First demonstrated
Unreported
First human implant
Unreported
Species studied
Human [1]
Regulatory status
510(k) K183579 cleared March 29, 2019; later 510(k) K232415 decision 08/21/2024, substantially equivalent. Class II, product code GZF [1][2]
Function
Peripheral nerve stimulation for severe intractable chronic pain of peripheral nerve origin, not for craniofacial pain [1]
Target tissue
Peripheral nerves [1]
Geometry and architecture
Field
Value and source scope
Interface type
Lead with eight cylindrical electrodes at the distal end, available integrated with the IPG or connected through ports [1]
Array layout
Unreported
Electrode count
8 per lead; single or dual lead configurations [1]
Pitch
Unreported
Electrode lengths
Unreported
Shank width and thickness
Unreported
Tip and exposed site geometry
Unreported
Contact coating
Unreported
Insulation
Unreported
Insertion method
Unreported
Anchoring and fixation
Unreported
Electrode and channel physics
Field
Value and source scope
Exposed site area
Unreported
Electrode material
Pt/Ir electrodes, polyurethane insulation [1]
Impedance (with measurement frequency)
Unreported
Noise floor or SNR
Unreported
Recording modality
Unreported
Sampling rate
Unreported
Stimulation capability
Unreported
Charge injection limit
Unreported
Reference and ground
Unreported
Tissue interface and bioresponse
Field
Value and source scope
Target tissue
Unreported
Insertion trauma and BBB disruption
Unreported
Vascular disruption risk
Unreported
Micromotion sensitivity
Unreported
Gliosis and encapsulation
Unreported
Neuron loss near sites
Unreported
Foreign-body response mitigation
Unreported
Typical failure modes
Unreported
System architecture
Field
Value and source scope
Onboard electronics
Ceramic hermetic IPG enclosure with feedthrough and printed circuit board, polyurethane-encapsulated wires and silicone overmold [1]
Data path
Therapy Disc powers and commands the implant by RF; the clinician programmer runs on an Android tablet over Bluetooth Low Energy [1]
Telemetry bandwidth
Unreported
Sampling rate
Unreported
Power
Implant has no battery in the description read; the externally worn Therapy Disc holds a rechargeable lithium-ion battery and is held by an adhesive clip or belt [1]
Thermal management
Unreported
Packaging and hermeticity
Unreported
MRI compatibility
Unreported
Surgical complexity
Unreported
Output connectors
Unreported
Performance envelope
Field
Value and source scope
Acute yield
Unreported
Chronic yield
Unreported
Stability over time
Unreported
Longevity
Unreported
Revision and explant experience
Unreported
Adverse events
Unreported
Notable demonstrations
Unreported
Clinical and preclinical evidence
Field
Value and source scope
Human subjects
Unreported
Preclinical cohort
Unreported
Follow-up duration
Unreported
Indications
Adults with severe intractable chronic pain of peripheral nerve origin, as sole agent or adjunct; trial devices for no more than 30 days [1]
Trials and registries
Unreported
Primary outcomes
Unreported
Key limitations
Cleared by 510(k) on predicate equivalence; no clinical trial data in the sources read. Pulse parameter ranges appear in a multi-device comparison table and were not attributed to the Nalu device here, so they read Unreported [1]
Engineering tradeoffs
Field
Value and source scope
Strengths
Unreported
Limitations
Unreported
Scaling constraints
Unreported
Version boundary
Description is from K183579 (2019). K232415 (decision August 21, 2024) is the latest record read; its document was not read for specs. A separate Nalu spinal cord stimulation clearance (K233801) is not covered.