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Specific indications: used to apply an electrical current to electrodes on patient's skin at some limited ● positions to function as:

• Relaxation of muscle spasms;
• Prevention or retardation of disuse atrophy
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion.
  Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for . the treatment of medical diseases and conditions.

Home Care various models of Powered Muscle Stimulator, HT-329M1, HT-329M2, HT-329M3, and HT-329M4

The provided text is a 510(k) premarket notification letter from the FDA. It does not contain information about acceptance criteria or a study proving device performance. This document is a regulatory approval notice, indicating that the Home Care Powered Muscle Stimulator (various models) is substantially equivalent to a legally marketed predicate device.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC results from this document.

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Specific indications: used to apply an electrical current to electrodes on patient's skin to function as:

• Relaxation of muscle spasms;
• Prevention or retardation of disuse atrophy
• Muscle re-education
• Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
• Maintaining or increasing range of motion.
• Clinical settings: The device should only be used under medical supervisions for adjunctive therapy for the treatment of medical diseases and conditions.

Home Care various models of Powered Muscle Stimulator, HT-311, HT-311N, HT-312

I apologize, but this document is a 510(k) clearance letter from the FDA for a Powered Muscle Stimulator. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter focuses on:

• Confirming that the device is substantially equivalent to legally marketed predicate devices.
• Outlining the regulatory classification and general controls provisions that apply to the device.
• Listing the indications for use for which the device was cleared.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device

Specific Indications: Used to apply an electrical current to electrodes on patients skin to function as:

• . Relaxation of muscle spasms.
• Prevention or retardation of disuse atrophy. .
• Muscle re-education. ●
• Immediate post-surgical stimulation of calf muscles to prevent venous . thrombosis.
• Maintaining or increasing range of motion. .

Clinical settings: The device should only be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.

Not Found

The provided document describes an FDA 510(k) clearance for the Homecare HT-326L device, a powered muscle stimulator. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document is primarily an approval letter confirming substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information.

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Intended to be applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Home Care various models of self-adhesive electrodes - FA, CA, TA, FI, TI, FR, CR, and R Series

The provided document is a 510(k) premarket notification letter from the FDA regarding self-adhesive electrodes. This type of document is a regulatory approval letter and does not contain information about acceptance criteria, study designs, or performance metrics in the way you've requested for a device evaluation.

Therefore, I cannot provide the requested information. The letter confirms that the device is substantially equivalent to legally marketed predicate devices, but it does not detail the technical performance criteria or the studies that would typically be described in a clinical or validation report for a novel medical AI device.

Ask a specific question about this device