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Transcutaneous Electrical Nerve Stimulation (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.

Electrical Muscle Stimulation (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 FDA 510(k) Clearance Letter for the "OTC 4-Channel Rechargeable TENS Unit" (K251429) does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria.

This document is a clearance letter, which means the FDA has determined the device is substantially equivalent to legally marketed predicate devices. It focuses on the regulatory aspects of the clearance, such as:

• Device name and regulation
• Regulatory class and product code
• Substantial equivalence determination
• General controls and additional controls applicable to the device
• References to FDA guidance documents and regulations (e.g., Quality System regulation, UDI Rule)
• Contact information for the FDA

Specifically, the document does NOT include:

1. A table of acceptance criteria and reported device performance: This type of data would typically be found in the actual 510(k) submission, not the clearance letter.
2. Sample size used for the test set and data provenance: Again, this is detailed information from the testing portion of the submission.
3. Number of experts and their qualifications for establishing ground truth: Not mentioned in this regulatory letter.
4. Adjudication method: Not applicable or mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study results: This applies to AI/CAD devices, and the TENS unit is a physical device, so such a study would not be relevant.
6. Standalone (algorithm only) performance: Not applicable for a TENS unit.
7. Type of ground truth used: Not applicable or mentioned.
8. Sample size for the training set: Not applicable for a TENS unit (unless it incorporates some form of adaptive AI, which is not indicated here).
9. How the ground truth for the training set was established: Not applicable for a TENS unit.

The provided text only states the Indications for Use for the TENS and EMS functions. To find the specific performance data and acceptance criteria, you would need to access the full 510(k) submission (if it were publicly available in that format, which it generally is not for the detailed technical reports). The clearance letter confirms that the FDA reviewed such data and found it adequate for substantial equivalence, but it does not reproduce that data.

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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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1) 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.

2) 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 from the FDA 510(k) clearance letter for the "3 in 1 TENS UNIT" (K251187) does not contain any information about acceptance criteria or the specifics of a study proving the device meets those criteria, particularly not for an AI/ML medical device.

The document is a standard FDA clearance letter for a Class II medical device (Transcutaneous Electrical Nerve Stimulator For Pain Relief). It primarily covers:

• Device Identification: Trade name, regulation number, product code.
• Regulatory Status: Declaration of substantial equivalence to a predicate device.
• General Controls: Mentions requirements like annual registration, listing, good manufacturing practice, labeling, and prohibitions against misbranding/adulteration.
• Additional Controls: Notes potential for special controls for Class II devices and references regulations like the Quality System (QS) regulation.
• Compliance: Reminds the applicant of various other FDA regulations (e.g., UDI Rule, MDR).
• Contact Information: Provides resources for further inquiries.
• Indications for Use: Describes the intended use for TENS (pain relief) and EMS (muscle performance).

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text. The information you're asking for typically comes from the premarket submission itself (which might include detailed validation studies, performance data, and the methodology for establishing acceptance criteria), not from the FDA's clearance letter. This type of detail is particularly crucial for AI/ML-based devices, which this TENS unit is not described as.

If you have a document describing the actual performance study and acceptance criteria for this specific device, please provide it, and I would be happy to help analyze it.

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1) 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.

2) EMS
The device is designed to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.

Not Found

The provided FDA 510(k) Clearance Letter for the "3 in 1 TENS UNIT" (K250759) does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to AI/algorithm-based medical devices.

This document is a standard FDA clearance letter for a Class II medical device (Powered Muscle Stimulator, TENS/EMS unit). It confirms that the device is substantially equivalent to legally marketed predicate devices and is subject to general controls and other regulations like the Quality System (QS) regulation.

Specifically, the letter does not mention:

• Any AI or algorithmic components of the device.
• Specific performance metrics (e.g., sensitivity, specificity, AUC) that would require a clinical study with acceptance criteria.
• Test sets, training sets, ground truth establishment, expert readers, or MRMC studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based solely on the provided text. The information required for your request (1-9) is typical for AI/ML-based medical devices that require performance validation, which is not described in this standard 510(k) clearance letter for a TENS/EMS unit.

This device, being a "Powered Muscle Stimulator" (TENS/EMS unit), typically undergoes electrical safety, electromagnetic compatibility (EMC), and performance testing related to its electrical output, waveform, and ability to deliver stimulation as intended, rather than AI-driven diagnostic or treatment algorithms.

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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.

Not Found

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

This document is a 510(k) clearance letter from the FDA for a Tens & Ems Device (TU1080). It states that the device is substantially equivalent to legally marketed predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

Therefore, I cannot provide the requested information. The letter only confirms FDA clearance based on substantial equivalence, which is a regulatory pathway, not a performance study report.

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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.

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