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The device of this submission is designed to temporarily relieve muscle soreness and pain in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom caused by exercise or normal household activities. Also used to stimulate healthy muscles to improve muscle performance.

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The provided text is an FDA clearance letter for a medical device: "TENS and EMS Unit." This letter indicates that the device has been found substantially equivalent to a legally marketed predicate device.

Crucially, this document does NOT contain information about acceptance criteria or a study proving the device meets those criteria, as typically found in a clinical study report or a 510(k) summary.

The letter is a regulatory document stating market clearance and does not detail the technical performance or supporting studies for the device. Instead, it refers to the device's "Indications for Use" and mentions regulatory compliance.

Therefore, I cannot provide the requested information from the given text.

To answer your questions, I would need access to the 510(k) summary or the full 510(k) submission for K251706, which would typically contain the performance data and details of any studies conducted.

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TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

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I am sorry, but the provided text does not contain information about the acceptance criteria or a study proving that the device meets such criteria.

The document is a clearance letter from the FDA for a "Wireless TENS & EMS Unit" (K243763). It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls, regulations, and reporting requirements for the manufacturer. It also includes the "Indications for Use" for the device.

However, it does not describe any specific performance acceptance criteria for the device, any study conducted to demonstrate that the device meets those criteria, or any details related to sample sizes, data provenance, expert qualifications, ground truth, or MRMC studies.

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The devices of this submission are designed to temporarily relieve muscle soreness and pain in the shoulder, wast, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom caused by exercise or normal household activities. Also used to stimulate healthy muscles to improve muscle performance.

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for an "OTC TENS & EMS Unit." This document primarily focuses on regulatory approval, substantial equivalence to predicate devices, and general controls and regulations. It does not contain any information about acceptance criteria for device performance, scientific studies, or data related to the device's efficacy or safety.

Therefore, I cannot provide the requested information regarding acceptance criteria and the study that proves the device meets them from this document. The document explicitly states:

• "We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices."
• "Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading."
• "FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies."

The 510(k) process primarily confirms substantial equivalence to a legally marketed predicate device, not necessarily a de novo clinical study proving performance against specific criteria in the way you've outlined.

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TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.

Not Found

I am sorry, but the provided text does not contain information about the acceptance criteria and the study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a Muscle and Nerve Stimulator TENS & EMS device. It states that the device is substantially equivalent to legally marketed predicate devices and outlines general controls, regulations, and reporting requirements.

While it includes the "Indications for Use" for the device, it does not describe any specific performance acceptance criteria or details of a study conducted to demonstrate the device's performance against such criteria. Therefore, I cannot provide the requested table or the other study-related information.

Ask a specific question about this device