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510(k) Data Aggregation
K Number
K142025Device Name
NEUROLUMEN PN-1000
Manufacturer
NEUROLUMEN, LLC
Date Cleared
2015-01-21
(180 days)
Product Code
ILY, GEX, GZJ, ISA, NHN
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
NEUROLUMEN, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Neurolumen is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.
The Neurolumen is also indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.
Device Description
The Neurolumen is a medical therapy device that delivers Transcutaneous Electrical Nerve Stimulation (TENS) and Low Level Laser Therapy (LLLT) to a patient's limbs.
The Neurolumen consists of a control unit and six wraps. Each wrap contains two laser diodes, 4 light emitting diodes, and one or two TENS gel pads. After applying the wraps to the feet, ankles, and legs, the control unit is able to provide up to 30 minutes of therapy on a single charge of the internal lithium-ion battery. A charger is provided for recharging the internal battery.
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K Number
K082223Device Name
NEUTROLUMENPN SYSTEM, MODEL 1000
Manufacturer
NEUROLUMEN, LLC
Date Cleared
2009-04-21
(258 days)
Product Code
ILY, GZJ
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
NEUROLUMEN, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LED Stimulation for therapeutic heat
The NeurolumenPN is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated
TENS Stimulation
The symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.
Device Description
NeurolumenPN System, Model 1000
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