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510(k) Data Aggregation
K Number
K202725Device Name
ETD4000
Manufacturer
TheraSigma, LLC
Date Cleared
2021-03-26
(190 days)
Product Code
LIH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
TheraSigma, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Interferential Current Stimulation: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
Device Description
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K Number
K201958Device Name
ETD Family of Electrotherapy Devices
Manufacturer
TheraSigma, LLC
Date Cleared
2020-08-04
(21 days)
Product Code
IPF, GZJ, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
TheraSigma, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ETD100 TENS Device: TENS Mode: Transcutaneous Electrical Nerve Stimulation for Pain Relief: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
ETD200 NMES Device: NMES Mode: Neuromuscular Electrical Stimulation: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding muscle disuse atrophy, muscle reeducation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
ETD300 TENS and NMES Combination Device: TENS Mode: Transcutaneous Electrical Nerve Stimulation for Pain Relief: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. NMES Mode: Neuromuscular Electrical Stimulation: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding muscle disuse atrophy, muscle reeducation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
ETD400 IFCS Device (IFCS = Interferential Current Stimulation): IFCS Mode: Interferential Current Stimulation: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
ETD500 TENS and IFCS Combination Device: TENS Mode:Transcutaneous Electrical Nerve Stimulation for Pain Relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. IFCS Mode: Interferential Current Simulation: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
ETD600 NMES and IFCS Combination Device: NMES Mode: Neuromuscular Electrical Stimulation: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding muscle disuse atrophy, muscle reeducation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. IFCS Mode: Interferential Current Simulation: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
ETD700 TENS and NMES and IFCS Combination Device: TENS Mode: Transcutaneous Electrical Nerve Stimulation for Pain Relief. Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. NMES Mode: Neuromuscular Electrical Stimulation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding muscle disuse atrophy, muscle reeducation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. IFCS Mode: Interferential Current Simulation. Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.
Device Description
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