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510(k) Data Aggregation
K Number
K022241Device Name
VERTIS PNT CONTROL UNIT, MODEL CU 100; VERTIS PNT SAFEGUIDE-CERVICAL, MODEL SG 102-XXX
Manufacturer
VERTIS NEUROSCIENCE, INC.
Date Cleared
2002-09-11
(62 days)
Product Code
NHI
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
VERTIS NEUROSCIENCE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Percutaneous Neuromodulation Therapy (PNT) is indicated for the symptomatic relief and management of chronic or intractable pain and/or as an adjunctive treatment in the management of post-surgical pain and post-trauma pain.
The PNT Control Unit is to be used with PNT Lumbar Safeguides for low back pain or PNT Cervical Safeguides for neck and/or upper back pain.
Device Description
The Vertis PNT System is designed for delivering percutaneous electrical stimulation (termed: Percutaneous Neuromodulation Therapy -PNT ). The Vertis PNT System is intended to be used in pain management by a physician (e.g., anesthesiologists or physical medicine and rehabilitation physicians) or on the order of a physician (e.g., by a physical therapist) in a clinic environment. The device system includes 3 major components:
- the Vertis PNT Control Unit a software-driven, ● five channel, AC powered nerve stimulator which generates the electrical stimulus;
- the sterile Safeguides which are sterile, needle electrodes; ●
- the Patient Cable - which interconnects the PNT Control Unit to the electrodes
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K Number
K011702Device Name
VERTIS PNT CONTROL UNIT, VERTIS PNT SAFEGUIDE KIDS, MODELS CU100, SGXXX
Manufacturer
VERTIS NEUROSCIENCE, INC.
Date Cleared
2001-12-21
(203 days)
Product Code
NHI
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
VERTIS NEUROSCIENCE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Percutaneous Neuromodulation Therapy (PNT) is indicated for the symptomatic relief and management of chronic or intractable low back pain and/or as an adjunctive treatment in the management of post-surgical low back pain and post-trauma low back pain.
The PNT Control Unit is to be used with a PNT Safeguide Kit - Lumbar.
Device Description
The Vertis PNT System is designed for delivering percutaneous electrical stimulation (termed: Percutaneous Neuromodulation Therapy - PNT ). The Vertis PNT System is intended to be used in pain management by a physician (e.g., I NT Uystein is intendousical medicine and rehabilitation physicians) or on the order of a physician (e.g., by a physical therapist) in a clinic environment. It is not intended for patient use. The device system includes 3 major components:
- the Vertis PNT Control Unit a software-driven, five channel, AC . powered nerve stimulator which generates the electrical stimulus;
- the sterile Safeguides which are sterile, needle electrodes, and ●
- the Patient Cable which interconnects the PNT Control Unit to the . electrodes
Ask a Question
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