Search Results

Thera-Cream™ is a conductive cream, which increases skin conductivity for electrotherapy treatment and was developed for use with the Prizm brand electrotherapy units and the Intelligent Textiles® brand of garment electrodes.

The Prizm Medical Inc.'s Thera-Cream™ product is used prior to electrode placement to reduce the impedance (resistance to alternating current), which increases the skin conductivity during electrotherapy treatment. Electrotherapy treatment includes the use of TENS (Transcutaneous Electrical Nerve Stimulators) and NMES (Neuromuscular Electrical Stimulators).

The provided text describes a 510(k) premarket notification for the Thera-Cream™ device. However, it does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The document focuses on:

• Device identification: Trade name, common name, classification, product code.
• Intended Use: "Thera-Cream™ is a conductive cream, which increases skin conductivity for electrotherapy treatment and was developed for use with the Prizm brand electrotherapy units and the Intelligent Textiles® brand of garment electrodes."
• Predicate devices: A list of previously marketed devices to which Thera-Cream™ is compared for substantial equivalence.
• Similarities and Differences to Predicate Devices: Thera-Cream™ shares the same intended use and incorporates "conductive copper salts" like the predicate Conduct-Mist™. The primary difference highlighted is Thera-Cream™'s "moisturizing cream base" versus Conduct-Mist™'s liquid/water base.
• FDA determination: The FDA's letter indicating substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.

Therefore, I cannot provide the requested information as it is not present in the given text.

To answer your request, the text would need to include:

1. Specific performance metrics (e.g., impedance reduction levels, conductivity values) along with thresholds that define "acceptance."
2. Details of a study (e.g., number of subjects, experimental design, results) demonstrating that the device achieved these performance metrics.

Ask a specific question about this device