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The TENSWave is indicated for management and symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.

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This document is a 510(k) clearance letter from the FDA for a device called "TENSWave," which is a Transcutaneous Electrical Nerve Stimulator for pain relief.

The provided text does not contain any information about acceptance criteria or a study proving the device meets those criteria. The letter primarily focuses on the device's substantial equivalence to predicate devices, its regulatory classification, and applicable general controls and regulations.

Therefore, an answer to the request to "Describe the acceptance criteria and the study that proves the device meets the acceptance criteria" cannot be generated from the given text.

The provided information only states:

• Trade/Device Name: TENSWave
• Regulation Number: 21 CFR 882.5890
• Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief
• Regulatory Class: Class II
• Product Code: GZJ
• Indications for Use: The TENSWave is indicated for management and symptomatic relief of chronic intractable pain, post-traumatic and postsurgical pain.

To answer the user's request, information regarding performance testing, clinical study results, and defined acceptance criteria would be necessary, which is absent in this FDA clearance letter.

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