Search Results

Wavelength Ultrasound Lotion is a conductive medium for use in diagnostic and therapeutic ultrasonic transducers and ultrasound monitors. This device is intended to be used as Apply Wavelength to treatment area. Remove after treatment with tissue or towels after use. For external use only.

Wavelength Ultrasound Lotion is a conductive medium for use in diagnostic and therapeutic ultrasonic transducers and ultrasound monitors.

The provided document is a 510(k) clearance letter from the FDA for a device called "Wavelength Ultrasound Lotion." This document grants market clearance based on substantial equivalence to a predicate device, which means it doesn't contain the type of detailed study information you're asking for.

510(k) clearances typically do not include:

• Acceptance Criteria and Reported Device Performance: This would be found in a performance study report, not the clearance letter itself. The clearance letter assumes the sponsor has demonstrated performance to be substantially equivalent to a predicate device.
• Sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information. These are elements of a detailed clinical or technical study, which are usually summarized in the 510(k) submission but not fully reproduced in the FDA's clearance letter.

Therefore, based solely on the provided text, I cannot answer your questions regarding acceptance criteria and the study that proves the device meets those criteria.

The document only states the device's name, its regulatory classification, and its intended use: "Wavelength Ultrasound Lotion is a conductive medium for use in diagnostic and therapeutic ultrasonic transducers and ultrasound monitors." It also provides basic usage instructions and contraindications.

Ask a specific question about this device