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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.

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This document is a 510(k) clearance letter for the ETD4000 Transcutaneous Electrical Nerve Stimulator for Pain Relief. It does not contain information typically found in a study proving a device meets acceptance criteria, such as performance metrics, sample sizes, ground truth establishment, or expert qualifications.

The letter confirms that the FDA has reviewed the device and found it substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements for marketing the device and includes the "Indications for Use" for the ETD4000.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them based on the provided text. The document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for test sets or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication methods.
• Results from a multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance studies.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

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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.

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This document is an FDA clearance letter for a family of electrotherapy devices (ETD Family: Models ETD100, ETD200, ETD300, ETD400, ETD500, ETD600, and ETD700). It establishes substantial equivalence to a predicate device but does not contain any information regarding acceptance criteria, device performance, or details of a study that proves the device meets specific criteria.

The letter focuses on:

• Acknowledging the 510(k) premarket notification.
• Stating the substantial equivalence determination.
• Outlining regulatory requirements for the device (registration, labeling, good manufacturing practice, etc.).
• Listing the indications for use for each model (TENS, NMES, IFCS modes).

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications from the provided text.

Ask a specific question about this device