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The intended use of the Migun Model HY-7000 Thermassage Energy Product is to provide thermassage therapy by delivering heat and soothing massage. Additionally, the infrared lamps provide topical heating for;

• temporary relief of minor muscle and joint pain, and stiffness o
• the temporary relief of minor joint pain associated with arthritis o
• the temporary increase in local circulation where applied o
• relaxation of muscles O

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The provided document is a 510(k) clearance letter from the FDA to Migun Medical Instrument Co. Ltd. for their HY7000 Thermassage Energy Product. This document does not contain information about acceptance criteria or a study proving the device meets those criteria.

FDA 510(k) clearances are based on demonstrating substantial equivalence to a predicate device, not necessarily on new studies proving specific performance criteria against predefined thresholds. The letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device... and have determined the device is substantially equivalent (for the indications referenced above and as described in the enclosure) to legally marketed predicate devices."

Therefore, I cannot extract the requested information (table of acceptance criteria, study details, sample sizes, expert qualifications, etc.) from this document because it is not present. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed performance study with explicit acceptance criteria for the new device.

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