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To be used for temporary relief of pain associated with sore and aching muscles in the neck, shoulder, waist, back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device named "TENS7000 Rechargeable." This document confirms the device's substantial equivalence to a predicate device and outlines regulatory requirements.

However, the letter does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness study results (effect size).
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size or ground truth establishment for a training set.

The document primarily focuses on regulatory approval based on substantial equivalence to a legally marketed predicate device, rather than detailed performance study results against specific acceptance criteria.

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