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The NMES is used for:
The device is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The work imposed on the muscles by the NMES programs is not suitable for rehabilitation and physiotherapy.

The TENS is intended for:
a) Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities;
b) The symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

The Portable Electro Stimulation Therapy Device (Model: LGT-2320ME, LGT-2320BE, and LGT-2320SP) is an electrotherapy device, mainly consists of the main unit, hand switch and electrodes, providing three channel groups (CH1-CH6, CH7-CH12 and CV Output channel) of TENS or NMES current.

The device is designed to deliver modulation waveform microcurrent to patient body via electrode pads which are connected to the output channel with lead wire, and the device is supplied by AC mains 100-240 Vac. The control circuit is enclosed in the enclosure of the main unit of the device, with hand switch and power supply driving circuit.

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Compression Therapy Device (Model: LGT‐2210DS) is intended for Prophylaxis and treatment of edema (Chronic venous edema, Lymphedema, Post‐mastectomy lymphedema).

Compression Therapy Device (Model: LGT‐2210DS) is intended exclusively for use by medical specialists and is only allowed to be used by qualified and instructed medical persons in clinical and hospital. The compression Therapy Device (Model: LGT‐2210DS) is designed to be used in patients over 22 years old.

The LGT‐2210DS is a compression therapy device comprised of an intermittent pneumatic controller, sleeves with 6‐chamber, 4‐chamber combined and connectable hoses. The working principle is the air inflating and deflating the sleeve sequentially to develop the circulating pressure on the human body, squeezing the proximal and distal of the limbs to promote blood circulation lymphatic system and improve body microcirculation.

The provided FDA 510(k) clearance letter is for a Compression Therapy Device (LGT-2210DS). This device is a physical therapy device and not an AI/ML medical device. Therefore, the document does not contain the information required to answer questions related to AI/ML device testing, such as acceptance criteria, performance metrics (sensitivity, specificity, AUROC), sample sizes for AI model testing, expert involvement in ground truth establishment, MRMC studies, or training set details.

The document primarily focuses on establishing substantial equivalence to a predicate device (Compressible Limb Therapy System MK300L) based on:

• Intended Use: Prophylaxis and treatment of edema (Chronic venous edema, Lymphedema, Post-mastectomy lymphedema).
• Technological Characteristics: Intermittent pneumatic compression, compressor and valve system, sequential inflation.
• Safety and Performance Bench Testing: Service life, reliability, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), usability (IEC 60601-1-6), software V&V (specifically cybersecurity as the main software aspect noted), and biocompatibility (ISO 10993 series).

No AI/ML components are mentioned or implied in this 510(k) submission. The "Software Verification and Validation Testing" section explicitly states: "There is no wireless connection, Bluetooth, internet connection in the device, and Power socket is only for battery charging connection. The client information can be exported by entered Password with USB flash drive. Testing related to Cybersecurity was performed." This confirms the software involved is minimal and not AI-driven.

Therefore, I cannot provide a response to the prompt's specific requirements, as the provided document does not contain information about an AI/ML medical device.

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