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Diathermy Component. Indications for Use: To generate deep heating within body tissues for the treatment of conditions such as relief of pain, muscle spasms, and joint contractures.

Muscle Stimulator Component To increase local blood flow, muscle re-education, relaxation of muscle spasms, prevention or retardation of disuse atrophy, and immediate post surgical stimulation of calves to prevent deep vein thrombosis.

SeliTherm Model C100

The provided text is a 510(k) premarket notification letter from the FDA for the SeliTherm Model C100 device. This document does not contain the kind of detailed information requested about acceptance criteria and study designs that would typically be found in a clinical study report or a more comprehensive premarket submission.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Information about experts used for ground truth.
• Adjudication methods.
• Details on multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Types of ground truth used (pathology, outcomes data, etc.).
• Sample size for training sets.
• How ground truth for training data was established.

The letter merely states that the device is "substantially equivalent" to legally marketed predicate devices for the indications for use listed. This phrase implies that the FDA has determined the new device performs as intended and is as safe and effective as a similar device already on the market, but it does not provide the specifics of the data used to reach that conclusion.

Therefore,Based on the provided text, I cannot answer the questions about the acceptance criteria and the study that proves the device meets those criteria. The document is an FDA 510(k) clearance letter, which confirms substantial equivalence to a predicate device but does not detail the specific performance studies, acceptance criteria, or methodology of such studies.

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Diathermy Component. To generate deep heating within-body tissues for the treatment of conditions such as relief of pain, muscle spasms, and joint contractures.

Selicor Models A100 and D100

This document is a 510(k) premarket notification letter from the FDA to Selicor, Inc. regarding their Shortwave Diathermy Devices, Models A100 and D100. It confirms that the devices are substantially equivalent to legally marketed predicate devices.

This document does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. It is solely an FDA clearance letter. Therefore, I cannot provide the requested information based on the provided text.

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