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510(k) Data Aggregation
K Number
K202110Device Name
MStim Drop Model: LGT-233
Manufacturer
Guangzhou Longest Science & Technology CO., Ltd.
Date Cleared
2021-11-05
(463 days)
Product Code
GZI, IPF
Regulation Number
882.5810Why did this record match?
Applicant Name (Manufacturer) :
**Guangzhou Longest Science **& Technology CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MStim Drop LGT-233 is intended to provide ankle dorsiflexion in individuals who have a dropped foot as a consequence of upper motor neuron injury. The device electrically stimulates muscles in the affected leg to provide ankle dorsiflexion of the foot and/or knee flexion or extension; thus, it also may improve the individual's gait. The MStim Drop LGT-233 may also:
·Prevent/retard disuse atrophy
· Maintain or increase joint range of motion
•Increase local blood flow
Device Description
The MStim Drop LGT 233 is a wearable foot drop device, which is mainly consist s of stimulator main unit, electrode lead wire, electrodes pad, leg bandage and battery charger. The stimulator main unit can be charge by the battery charger.
The device can control the out stimulation and treatment time setting by APP application provided by the manufacturer, and it can trigger and control the pulse stimulation on and off by detecting the swing phase of gait during walking. The device was design to use FES (Functional Electrical Stimulation) to treat and improve the patient s foot drop and help to improve walking ability. It has two modes: Training mode, Walk mode. Training mode is suitable for muscle training when the patient is seated or lying down (patient lacking active training), which can promote muscle recover, prevent muscle atrophy, improve joint range of motion, and increase local blood flow. Walk mode is walking with the electrical stimulation.
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K Number
K201845Device Name
Portable Electro-Stimulation Therapy Device, Model: LGT-232(US)
Manufacturer
Guangzhou Longest Science & Technology Co., LTD.
Date Cleared
2020-10-08
(94 days)
Product Code
NGX, NUH, NYN
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
**Guangzhou Longest Science **& Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Portable Electro-Stimulation Therapy Device, model LGT-232(US) is used to: Stimulate healthy muscles in order to improve or facilitate muscle performance. It is to be used by adults only.
Portable Electro-Stimulation Therapy Device, model LGT-232(US) in TENS mode is used for:
1. Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities;
2. The symptomatic relief and management of chronic, intractable pain associated with arthritis.
Device Description
The LGT-232(US) is a lightweight and portable multifunctional electrotherapy device that provides NMES or TENS current. The device consists of the main unit, charging case, charger connector, FDA cleared self-adhesive electrodes (K183154), indicator light, main unit cable, on/off button, decreasing intensity button, and increasing intersity button to complete the function. The device can also be connected to a mobile phone through Bluetooth, and be controlled by the MStim Sport Application on the mobile device to choose the training programs and adjust pulse output intensity. The MSim Sport App can be downloaded from App Store. MStim Sport has up to seven training programs. These include Endurance, Resistance, Strength, Explosive Strength, Potentiation, Training Recovery and Pain Relief programs. The programmed electrical pulses will transfer through electrode plates to the suggested area of the body where the electrodes are placed.
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K Number
K182020Device Name
Portable Electro-Stimulation Therapy Device
Manufacturer
Guangzhou Longest Science & Technology Co., Ltd.
Date Cleared
2020-09-17
(783 days)
Product Code
NGX, NUH, NYN
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
**Guangzhou Longest Science **& Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Portable Electro-Stimulation Therapy Device, model LGT-231 is to be used by adults only and has two modes NMES and TENS.
NMES is used to: stimulate healthy muscles in order to improve or facilitate muscle performance.
TENS is used to:
1. Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.
2. Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
Device Description
The Portable Electro-Stimulation Therapy Device, model LGT-231 is a dual channel stimulator which sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin with two operational modes and powered by rechargeable lithium battery; the device system is made up of mobile app MStim Reha, main unit and electrodes.
The Mobile App MStim Reha provides access to treatment controls for Portable Electro-Stimulation Therapy Device from a compatible device for selecting a pre-programmed output mode, adjusting frequency, pulse width and treatment time. Software operating environment of Mobile App MStim Reha are Android 4.3 or later mobile phone, with 4.0 Bluetooth and iOS 8.0 or later iPhone mobile phone, with 4.0 Bluetooth. Click the MStim Reha Application installation package on the phone to install the application. MStim Reha Application and the device can be connected via Bluetooth.
The main unit provides access to adjust the intensity up or down, put ON/OFF the main unit.
The two modes that Portable Electro-Stimulation Therapy Device, model LGT-231 employs are neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS). Neuromuscular electrical stimulation (NMES) and transcutaneous electrical stimulation (TENS) target different nerve groups of the body.
TENS is specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. TENS use tiny electrical impulses sent through the skin to nerves to modify the pain perception. TENS does not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. Self-adhesive electrodes are placed on the skin close to the area of pain.
NMES targets the muscle itself, specifically through the motor nerves. This allows the NMES machine to create a muscle contraction to recruit more muscle fibers when training: warming up or recovering. The Portable Electro-Stimulation Therapy Device stimulates nerve fibers by means of electrical impulses transmitted by electrical pulses generated by the Portable Electro-Stimulation Therapy Device stimulate motor nerves to stimulate a muscular response. Depending on the parameters of the electrical impulses (pulse frequency, duration of contraction, duration of rest, and total session duration), different types of muscle work can be imposed on the stimulated muscles. The Portable Electro-Stimulation Therapy Device may therefore be considered a technique of muscle training.
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K Number
K191856Device Name
Compression Therapy Device
Manufacturer
Guangzhou Longest Science & Technology Co., Ltd.
Date Cleared
2020-03-19
(252 days)
Product Code
JOW
Regulation Number
870.5800Why did this record match?
Applicant Name (Manufacturer) :
**Guangzhou Longest Science **& Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Compression Therapy Device (Model: LGT-2201DVT) is intended to prevent DVT (Deep Vein Thrombosis) by improving the blood velocity of patients.
LGT-2201DVT is Circulation Enhancement, Deep Vein Thrombosis Prophylaxis, Edema - Chronic, Extremity Pain Incident to Trauma or Surgery, Leg Ulcers, Venous Stasis / Venous Insufficiency.
Device Description
Compression Therapy Device LGT-2201DVT a compression therapy device comprised of intermittent pneumatic controller, sleeves and connectable hose. 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. Besides, prevent thrombus, reduce limbs drops and this kind disease which is related to blood and lymph circulation directly or indirectly.
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K Number
K191862Device Name
Compression Therapy Device Model LGT-2200SP
Manufacturer
Guangzhou Longest Science & Technology Co., Ltd.
Date Cleared
2019-10-29
(110 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
**Guangzhou Longest Science **& Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Compression Therapy Device LGT-2200SP is intended for the temporary relief of minor muscle aches and for the temporary increase in circulation to the treated areas, it can simulate kneading and stroking of tissues by using an inflatable garment.
Device Description
Compression therapy device LGT-2200SP is a powered inflatable tube massager, comprised of an air compressor with intermittent pneumatic controller, 4-chamber sleeves covered with Polyether Nylon Fabric, and a connectable hose for connecting the device to the sleeves. The case of main unit body is made from ABS plastic. The device can be powered by an external power supply, or be powered by an internal lithium ion battery. The sleeves have 4-chambers and different applicable body areas, such as the Arm/ Leg/ Waist, hip and thigh/ Calf and foot. The sleeves can be inflating sequentially to apply the circulating pressure on the target body areas which controlled by the main unit. The device simulates manual kneading and stroking of tissues by sequential inflated sleeves, to temporarily relieve minor muscle aches and/or pains and to temporarily increase circulation to the treated areas.
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K Number
K182108Device Name
Portable Electro-Stimulation Therapy Device
Manufacturer
Guangzhou Longest Science & Technology Co., Ltd.
Date Cleared
2019-04-26
(266 days)
Product Code
NUH, GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
**Guangzhou Longest Science **& Technology Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Portable Electro-Stimulation Therapy Device, model LGT-235 is indicated for the Symptomatic relief of chronic intractable pain, Post-traumatic pain and Post-surgical pain of the arms and legs.
Device Description
The Portable Electro-Stimulation Therapy Device, model LGT-235 is a stimulator which sends gentle electrical current to underlying nerves via electrodes (Knee brace or self-adhesive electrode) applied on the skin with two operational modes and powered by rechargeable lithium battery; the device system is made up of mobile app MStim Arth, main unit and electrodes (Knee brace and self-adhesive electrode).
The Mobile App MStim Arth provides access to treatment controls for Portable Electro-Stimulation Therapy Device from a compatible mobile device for selecting a pre-programmed output mode and treatment time.
The main unit provides access to adjust the intensity up or down, put ON/OFF the main unit.
The two modes that Portable Electro-Stimulation Therapy Device, model LGT-235 employs are transcutaneous electrical stimulation (TENS) and Microcurrent (MCR).
TENS and MCR are both specifically targets the sensory nerves, which are responsible for sending pain signals to the brain. TENS and MCR use tiny electrical impulses sent through the skin to nerves to modify the pain perception. TENS and MCR do not cure any physiological problem; it only helps control the pain, this activates the underlying sensory nerves. Knee brace is placed on the leg or arm close to the area of pain.
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