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510(k) Data Aggregation
(105 days)
The DT-600 is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (EMSamond transcutaneous electrical nerve stimulation (TENS).
As a EMS device, DT-600 is indicated for the following conditions:
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· Relaxation of muscle spasms
As a TENS device, the DT-600 is indicated for the following conditions: -
· For symptomatic relief of chronic intractable pain.
The DT-600 is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (EMSamond transcutaneous electrical nerve stimulation (TENS).
The provided document is a 510(k) clearance letter from the FDA for a device named DT-600. It asserts substantial equivalence to a predicate device and outlines the indications for use. However, this document does not contain any information regarding specific acceptance criteria, study data, sample sizes, expert qualifications, or details about comparative effectiveness studies (MRMC or standalone).
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria using only the provided text. The document is solely a regulatory clearance letter, not a study report or clinical trial summary.
To answer your questions, I would need additional documentation such as:
- A clinical study report
- A summary of safety and effectiveness (SSE) or a substantial equivalence submission (510(k) summary) that would typically accompany such a clearance letter and include details about performance testing.
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(41 days)
The DT-1200 series is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (EMS) and transcutaneous electrical nerve stimulation (TENS).
As a EMS device, (available for DT-1200, DT-1200M and DT-1200PM) the DT-1200 is indicated for the following conditions:
- Relaxation of muscle spasms
- Prevention or retardation of disuse atrophy
- Increasing local blood circulation
- Muscle re-education
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
- Maintaining or increasing range of motion
As a TENS device, (available for DT-1200T and DT-1200T and DT-1200PT) the DT-1200 is indicated for the following conditions:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
The DT-1200 series is a multifunction electrotherapy device with various treatment modes that allow for neuromuscular electrical stimulation (EMS) and transcutaneous electrical nerve stimulation (TENS).
I am sorry, but the provided text is a 510(k) clearance letter for the DT-1200 series device. It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.
Ask a specific question about this device
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