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Health Zone/Healthy Vibes Mini Rechargeable Infrared Massager, Model KM-213H; Health Zone/Healthy Vibes Infrared Massager Set, Model KM-201

This FDA 510(k) letter for the Health Zone/Healthy Vibes Mini Rechargeable Infrared Massager and Infrared Massager Set (models KM-213H and KM-201, respectively) does not contain the information requested about acceptance criteria or a study proving the device meets said criteria.

The letter is primarily a declaration of substantial equivalence to previously marketed predicate devices, which allows the manufacturer to market the new devices. It confirms that the devices are regulatory Class II and are subject to general controls.

Therefore, I cannot provide the detailed information requested in the prompt based on this document. The document primarily focuses on regulatory approval based on equivalence, not on specific performance metrics or studies.

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• RELIEVES MINOR MUSCLE ACHES AND PAINS
• DRY HEAT THERAPY FOR BODY SURFACES

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The provided document is a 510(k) premarket notification response from the FDA regarding two infrared massagers (Models KM-213H and KM-201) manufactured by Windmere Corporation. This type of document declares substantial equivalence to previously marketed devices and permits the devices to be marketed, subject to general controls.

Therefore, this document does not contain any information about acceptance criteria or supporting studies because it is a regulatory clearance letter, not a device performance report or clinical study summary.

Specifically:

• It does not list any acceptance criteria for device performance.
• It does not describe any study conducted to prove the devices meet such criteria.
• It does not include any of the detailed information requested in the prompt, such as sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.

The letter explicitly states: "We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This means the determination is based on the devices being similar enough to existing devices, not on new performance studies against specific acceptance criteria for these particular models.

The "Enclosures" mentioned in the letter might contain the indications for use and potentially documentation from Windmere Corporation's 510(k) submission, which could include performance data if it was relevant for comparison to a predicate device. However, this specific letter does not provide that information.

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