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The BioFlex "" Professional Therapy System is used by trained health care professionals and is indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue.

The "Indications for Use" for this device cover three therapeutic applications;

• relief of neck and shoulder pain, and .
• relief of muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting . relaxation of muscle tissue.

The BloFlex ™ Professional Therapy System is designed for clinical applications to provide low level light therapy and record and display treatment sessions. This device is composed of:

• software {that runs in a qualified, ancillary computer}, ●
• proprietary hardware and software, and .
• flexible treatment heads. ●

The BioFlex ™ Professional Therapy System is a "multi-mode" low level light treatment system configured for multiple treatment heads powered by a flexible protocol controller that delivers various treatment protocols.

The provided document is a 510(k) summary for the BioFlex™ Professional Therapy System. It details the device's intended use and its substantial equivalence to a predicate device. However, it does not contain any information about specific acceptance criteria or an efficacy study that would prove the device meets such criteria.

The document discusses:

• The device's classification (Class II, Infrared Lamp).
• Its intended use: "to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue."
• Its substantial equivalence to the "Super Nova™ via K001179" predicate device.
• That safety and efficacy have been tested and confirmed, and that the company maintains an in-house reporting system for adverse events.
• Factory calibration tests are conducted to verify accuracy and calibration.

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

To answer your request, a document detailing the results of a clinical study, performance testing, or a description of the acceptance criteria would be needed.

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