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Specific indications: it is used for the symptomatic relief and management of chronic, intractable pain and as an adjunctive treatment in the management of post surgical and post traumatic acute pain problems. Clinical settings: should be used under the instruction or prescription by qualified health professionals prior to the applications of the device at home or hospital facilities.

Sanidad TENS-Duo Mode GP8016N

This document is a 510(k) premarket notification decision letter from the FDA for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms the device's substantial equivalence to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.

Therefore, I cannot provide the requested table and study details. This document is purely administrative approval based on substantial equivalence, not a detailed technical report of device performance or clinical trials.

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Specific indications: used to apply an electrical current to electrodes on a patient's skin to function as: Relaxation of muscle spasms. Prevention or retardation of disuse atrophy Increasing local blood circulation. Maintaining or increasing range of motion.

ROLOR POWERED MUSLCE STIMULATOR GP-8016M

The provided text is a 510(k) premarket notification letter from the FDA regarding a powered muscle stimulator. It does not contain any information about acceptance criteria, study details, or device performance data. Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

The document primarily focuses on:

• The FDA's determination of substantial equivalence for the "ROLOR POWERED MUSCLE STIMULATOR GP-8016M".
• The classification of the device (Class II - Product Code: IPF).
• General regulatory requirements for the device.
• The intended use of the device, which includes relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, and maintaining or increasing range of motion.

No performance data, study designs, sample sizes, expert qualifications, or ground truth methodologies are mentioned.

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Temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.

Sanidad Far-Infrared Mini Lamp, FI-3646

This document is an FDA 510(k) clearance letter for the Sanidad Far-Infrared Mini Lamp, FI-3646. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory classifications, general controls, and compliance requirements, but it does not detail any performance studies conducted by the manufacturer for this specific device.

Therefore, I cannot provide the requested information based on the provided text. The document is strictly a regulatory approval notice, not a scientific study report.

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Temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains.

Sanidad Thermal Far-Infrared Wave Lamp, AP-2018

This document is a 510(k) premarket notification approval letter from the FDA for the Sanidad Far-Infrared Wave AP-2018. It states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets or ground truth establishment.

The letter is a regulatory approval and merely outlines the "Indications for Use" for the device: "Temporarily increases local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains."

To answer your request, I would need a different document, specifically the premarket notification submission itself or a summary of its contents, which would typically include the study details you are asking for. The provided document is an approval letter, not the study results.

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