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510(k) Data Aggregation
K Number
K211094Device Name
Nerve and Muscle Stimulator
Manufacturer
Shenzhen XFT Medical Limited
Date Cleared
2021-07-08
(87 days)
Product Code
IPF, HCC
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen XFT Medical Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
sEMG:
Biofeedback, Relaxation & Muscle Re-Education purposes;
NMES (muscle stimulation) and sEMG triggered stimulation (Including ETS, PAS and MIRROR Mode):
1) Relaxation of muscle spasms;
2) Prevention or retardation of disuse atrophy;
3) Increasing local blood circulation;
4) Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis;
5) Maintaining or increasing range of motion;
6) Stroke Rehab by Muscle re-education.
Device Description
The Nerve and Muscle Stimulator (model: XFT-2003K) is an electrical muscle stimulator for contraction of muscles as indicated above. The Nerve and Muscle Stimulator (model: XFT-2003K) is also an electromyography device. It is intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves and to monitor and display the electrical activity produced by nerves. The indications for use are muscle reeducation, relaxation and biofeedback.
Nerve and Muscle Stimulator (model: XFT-2003K) is powered by MAINS SUPPLY AC 100-240V, 50-60Hz, and used together with Electrode cup (including Sponge).
The device is used for prescription. It is neither for life-supporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterilized.
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K Number
K193276Device Name
Nerve and Muscle Stimulator
Manufacturer
Shenzhen XFT Medical Limited
Date Cleared
2020-09-23
(302 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen XFT Medical Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nerve and Muscle Stimulator (Model: XFT-2001EA) is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the Nerve and Muscle Stimulator (Model: XFT-2001EA) electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Electrical Stimulation (FES) may include prevention/retardation of disuse atrophy, increased local blood flow, muscle reeducation, and maintained or increased joint range of motion.
Device Description
Nerve and Muscle Stimulator (Model: XFT-2001EA) is a wearable and DC 3.7V rechargeable lithium battery powered multifunction device, and integrated metal (stainless-steel) electrodes, offering Functional Electrical Stimulation (FES) in device. It can be attached to the leg just below the knee, near the head of the fibula. During a gait cycle, the Nerve and Muscle Stimulates the common peroneal nerve via metal electrode, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle.
The Nerve and Muscle Stimulator is a microprocessor-controlled device, and uses a smart phone operating application (APP) to store device, user and configuration information via Bluetooth. it can be operated by both smart phone application and the control panel of the device.
Nerve and Muscle Stimulator has 3 working mode, Walk Mode, Training Mode and Evaluation Mode. The walk mode and training mode which can give certain electrical pulses through metal electrode to the proposed area of the leg where the Nerve and Muscle Stimulator are placed. There is no electrical stimulation in the evaluation mode, it is intended to collect the tilt angle data generated by the Stimulator during the patient's walking, and can calculate the recommend parameters based on the collected data.
The control panel of the device has the operating elements of ON/OFF touch button, OLED display, mode selection touch button, intensity touch button and USB port for battery charging. The OLED display can show battery power, selected mode, current intensity and indication of a pause.
The stimulator will connect the APP via Bluetooth, user can set the parameters, mode selection, and intensity adjustment of the stimulation by APP. Logout of the APP or disconnect the Bluetooth, the stimulator can continue to work.
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K Number
K193275Device Name
Nerve and Muscle Stimulator
Manufacturer
Shenzhen XFT Medical Limited
Date Cleared
2020-04-11
(137 days)
Product Code
IPF, GZJ
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen XFT Medical Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Over-The-Counter Use: TENS[ (Program 1~9, Program 15 (Frequency < 5Hz or > 15Hz)]: XFT-2000 is used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. XFT-2000 is also intended for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. NMES[ (Program 10~14, Program 15(5Hz≤Frequency≤50Hz)]: XFT-2000 is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. XFT-2000 is also intended to temporarily increase local blood circulation in health muscles of lower extremities. Prescription Use: XFT-2000 is intended for the following use: - Relaxation of muscle spasms - Prevention or retardation of disuse atrophy - Increasing local blood circulation - Muscle re-education - Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis - Maintaining or increasing range of motion - Adjunctive treatment in the management of post-surgical and post-traumatic acute pain.
Device Description
Nerve and Muscle Stimulator (model: XFT-2000) is based on the principles of neuromuscular electrical stimulation (NMES) and transcutaneous electrical nerve stimulation (TENS).The instrument has two independent channels, easy to operate and use. It can relieve muscle spasm, prevent or delay disuse muscle atrophy, promote local blood circulation, promote muscle function recovery, stimulate calf muscle after surgery to prevent venous thrombosis and maintain or increase the range of activity, and assist in the management of post-operative and post-traumatic acute pain problems. Nerve and Muscle Stimulator (model: XFT-2000) is powered by DC adapter or 3 dry AAA batteries, and used together with self-adhesive Electrode. The device is for both prescription and over the counter. It is neither for lifesupporting nor for implanting. It does not contain any drug or biological product and it does not need to be sterilized.
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K Number
K162718Device Name
Foot Drop System (Model XFT-2001D)
Manufacturer
SHENZHEN XFT Medical Limited
Date Cleared
2017-11-30
(427 days)
Product Code
GZI
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN XFT Medical Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
XFT-2001D Foot Drop System is intended to address the lack of ankle dorsiflexion in patients who have sustained damage to upper motor neurons or pathways to the spinal cord. During the swing phase of walking, the XFT-2001D electrically stimulates the appropriate muscles that cause ankle dorsiflexion and may thus improve the individual's gait. Medical benefits of Functional Stimulation (FES) may include prevention/retardation of disuse attophy, increased local blood flow, muscle re-education, and maintained or increased joint range of motion.
Device Description
Nerve and Muscle Stimulator (Foot Drop System) is a battery-operated, electrical stimulator that can be used for functional electrical stimulation (FES). Nerve and Muscle Stimulator (Foot Drop System) is an external functional electrical stimulator. It is a small device that attaches to the leg just below the knee, near the head of the fibula. During a gait cycle, Nerve and Muscle Stimulator (Foot Drop System) stimulates the common peroneal nerve, which innervates the tibialis anterior and other muscles that cause dorsiflexion of the ankle. The Nerve and Muscle Stimulator (Foot Drop System) consists of the Patient Kit and the Clinician Kit. The Patient Kit comprises of all the components and accessories that the patient will take home and use. The Clinician System includes the Medical Records Management Software.
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