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T.E.N.S. stimulation is used for symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain.

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I am sorry, but based on the text provided, there is no information about the acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification approval letter for the "Pain Buddy" Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, stating that the device is substantially equivalent to a legally marketed predicate device.

The document includes:

• Trade/Device Name: Pain Buddy
• Regulation Number: 21 CFR 882.5890
• Regulation Name: Transcutaneous electrical nerve stimulator for pain relief
• Regulatory Class: II
• Product Code: NUII
• K Number: K102051
• Indications for Use: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic pain. The device is for Over-The-Counter Use.

However, it does not contain the specific details requested regarding:

• A table of acceptance criteria and reported device performance.
• Sample sizes, data provenance, or details of a test set.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness studies or human reader improvement with AI.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or how its ground truth was established.

This document is primarily an FDA approval letter for substantial equivalence, not a detailed study report.

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