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The "Buzbee" is a battery operated pocket-sized transcutaneous electrical nerve stimulator used to apply an electrical current through fixed surgical steel electrodes on the device to a patient's skin (without coupling gel) for symptomatic pain relief. For the symptomatic relief of chronic intractable, post-traumatic and post-surgical pain.

The "Buzbee" is a battery operated pocket-sized transcutaneous electrical nerve stimulator used to apply an electrical current through fixed surgical steel electrodes on the device to a patient's skin (without coupling gel) for symptomatic pain relief.

This document is a 510(k) clearance letter from the FDA for a device called "Buzbee," a transcutaneous electrical nerve stimulator (TENS). It's a regulatory document confirming substantial equivalence, not a study report detailing acceptance criteria or device performance data. Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in this document.

The document indicates:

• Device Name: Buzbee
• Regulatory Class: II
• Product Code: GZJ
• Intended Use: Battery operated pocket-sized transcutaneous electrical nerve stimulator for symptomatic pain relief (chronic intractable, post-traumatic, and post-surgical pain).
• Operating Mechanism: Applies electrical current through fixed surgical steel electrodes to a patient's skin without coupling gel.

To obtain the information requested, a different type of document (e.g., a clinical study report, a technical file submitted for the 510(k)) would be needed. This letter only confirms that the device is substantially equivalent to a predicate device and can be marketed.

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