Search Results

The Power Twin 21 is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscle.

Not Found

This document is a 510(k) clearance letter from the FDA for a device called "Power Twin 21." It primarily addresses the regulatory approval process and states that the device is substantially equivalent to a legally marketed predicate device.

Critically, this document does not contain any information about acceptance criteria for device performance, nor does it describe any study proving the device meets such criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory classification and compliance, not on performance studies or clinical trial results. Manufacturers typically submit performance data in their 510(k) premarket notification, but that data is not included in the FDA's clearance letter itself.

Ask a specific question about this device