(21 days)
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.
Not Found
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.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).