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Intended for the symptomatic relief and management of chronic intractable pain, and as an adjunctive treatment for postsurgical and post-trauma acute pain. The device is indicated for over the counter use.

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The provided text is a 510(k) clearance letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device, S21 OTC Transcutaneous Electrical Nerve Stimulator.

It focuses on establishing the substantial equivalence of this TENS device to legally marketed predicate devices and outlines the regulatory requirements the manufacturer must adhere to.

Crucially, this document DOES NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) clearance process for devices like TENS machines primarily relies on demonstrating substantial equivalence to existing, legally marketed predicate devices. This often involves showing that the new device has the same intended use, technological characteristics, and safety and effectiveness profile as the predicate. It does not typically involve detailed performance studies with acceptance criteria in the manner that an AI/ML medical device might undergo for a de novo or PMA submission.

Therefore, I cannot fulfill your request for information about acceptance criteria and the study that proves the device meets them based on the provided text. The document describes a regulatory clearance process, not a clinical performance study with acceptance criteria.

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