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Air compression Leg Massager is intended for the temporary relief of minor muscle aches and pains and for the temporary increase in circulation to the treated areas in people who are in good health, it can simulate kneading and stroking of tissues by using an inflatable garment.

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The provided text is a 510(k) clearance letter from the FDA for an "Air compression Leg Massager." It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain any information regarding:

• Acceptance criteria for device performance.
• A study proving the device meets acceptance criteria.
• Sample size for a test set.
• Data provenance for a test set.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This document is solely an FDA clearance letter based on substantial equivalence, not a detailed report of a performance study. K240373 refers to a Class II device (Powered Inflatable Tube Massager) which typically undergoes a different type of review process than novel AI/ML-driven diagnostic devices that would require such extensive performance data.

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