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510(k) Data Aggregation
K Number
K221303Device Name
Neuspera Nuity System
Manufacturer
Neuspera Medical Inc.
Date Cleared
2023-04-11
(341 days)
Product Code
GZF
Regulation Number
882.5870Why did this record match?
Applicant Name (Manufacturer) :
Neuspera Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neuspera Nuity™ System (NNS) 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 Neuspera Nuity™ System (NNS) is also used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant.
Device Description
The Neuspera Nuity™ System is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The System consists of an implantable pulse generator (IPG), electrode array, surgical implant tools, wireless worn transmitter, clinician programmer, a patient controller, and undergarments. The implantable pulse generator is a miniature implanted neurostimulator, powered by an externally worn wireless transmitter device which contains a rechargeable battery.
Same as the predicate, the Neuspera Nuity™ System utilizes pulsed electrical current to create an energy field that acts on the targeted nerve to inhibit the transmission of pain signals to the brain. The Neuspera Nuity™ System may also be used during the trial period before recommendation for permanent implant.
The Neuspera Nuity™ System (NNS) is comprised of the following components: Neuspera Implanted Pulse Generator (IPG) Or Neuspera Implanted Microstimulator, Electrode Array, Surgical/Implant Tools, Externally Worn Wireless Transmitter, Clinician Programmer and Patient Controller.
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K Number
K202781Device Name
Neuspera Neurostimulation System (NNS)
Manufacturer
Neuspera Medical Inc.
Date Cleared
2021-08-27
(339 days)
Product Code
GZF
Regulation Number
882.5870Why did this record match?
Applicant Name (Manufacturer) :
Neuspera Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neuspera Neurostimulation System (NNS) 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 Neuspera Neurostimulation System (NNS) is also used for trial stimulation (no longer than 30 days) to determine efficacy before recommendation for a permanent (long term) implant.
Device Description
The Neuspera Neurostimulation System is used for peripheral nerve stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The System consists of an implantable pulse generator (IPG), electrode array, surgical implant tools, wireless worn transmitter, clinician programmer and a patient controller. The implantable pulse generator is a miniature implanted neurostimulator, powered by an externally worn wireless transmitter device which contains a rechargeable battery.
Ask a Question
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