Search Results
Found 2 results
510(k) Data Aggregation
K Number
K221092Device Name
Transcutaneous Electrical Nerve Stimulator Model: ST-304
Manufacturer
Shenzhen Future Electronic Co., Ltd
Date Cleared
2022-09-13
(153 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Future Electronic Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
To be used for temporary relief of pain associated with sore and aching muscles in the back of neck, due to strain from exercise or normal household and work activities.
- Neck Pad is used in back of neck.
Device Description
The subject device is intended to use on back of neck and it designed accord with human body cervical physiological curvature of streamlined ring design. It is a body-worn and home-use device. It uses low-frequency electronic therapy and designed to temporary relief of pain associated with sore and aching muscles in the back of neck. It only has one model: ST-304.
The trade name of the subject device is Transcutaneous electrical nerve stimulator.
The Transcutaneous electrical nerve stimulator (model: ST-304) consists of a main unit and Type C-USB charging cable. The main unit consists of shell, lithium battery (only 1pcs), neck electrodes pads (a pair of fixed neck electrodes pads), lower shell connector and control buttons and silicone pads. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is titanium material (Gr.2). There are only 1 pcs lithium battery in-build in main unit. The model of lithium battery is KRL 103040.
The neck electrodes pads (a pair of fixed neck electrodes pads) are a kind of Titanium material, and the detail content as following description and as the classify of ASTM F67 2017 it is under Gr2.
The Transcutaneous electrical nerve stimulator (model: ST-304) power supply is 3.7V DC using built-in lithium battery(1200mAh). The built-in lithium battery can be recharged. But the power adapter (Input: 100-240V~, 50/60Hz,0.7A, Output: 5V== 1000mA) is not the parts of the subject device so it shall be supplied by the user. There are two fixed neck electrodes pads on the main unit. The material of neck electrodes pads is Titanium material (Gr.2).
The Transcutaneous electrical nerve stimulator (model: ST-304) totally has 3 modes. The stimulation has 2 modes for stimulating and 15 output Intensity Levels for each mode, so the device can give certain electrical pulse through the neck electrodes pads on the intact skin of back neck to help users to temporary relief of pain. The heating only has 1 mode for heating and it can also provide a constant temperature of 32℃ to 38℃ to provide a warming sensation. The stimulation function and heating function can be used separately or simultaneously. The neck electrodes pads provide users with back of neck stimulation and heat to warm and comfort the muscles of the back of neck.
The main unit provides access to adjust the intensity up or down and adjust stimulating mode, put ON/OFF the main unit and heating function.
The Intensity level of electrical stimulation and heating function are easily controlled by the end user using manual, push-button controls. The push-button controls are consisted of four button which are Switch on/off button/mode switch button, heating button, Intensity increase button and Intensity decrease button.
The default stimulation time is 10 minutes, and the user cannot adjust but could turn off the device during working condition.
Transcutaneous electrical nerve stimulator (model: ST-304) has 2 types stimulation modes: Mode 1, Mode 2.
Before use the device to wipe the Electro Therapy Conductive Gel on the Neck Electrode Pads. But the Electro Therapy Conductive Gel is not the part of subject device so it shall be supplied by the user.
Principle of operation:
The Transcutaneous electrical nerve stimulator (model: ST-304) sends low-voltage electrical pulses to specific nerves via two fixed neck electrodes pads applied on the intact skin of back of neck and powered by rechargeable lithium battery. The purpose is to temporarily relieve pain. By adjusting the output voltage and frequency to produce the low-voltage electrical pulses and achieve the effect of electrotherapy. Voltage regulation is realized by the Boost Converter circuit, which controls the voltage amplitude by modifying the PWM control circuit. After that, the voltage is released to the electrode through the analog circuit, and the time change of the output voltage is controlled by modifying the PWM frequency to achieve the specific electrotherapy effect.
Ask a Question
K Number
K213745Device Name
Air Compression Therapy Device, model: ST-502
Manufacturer
Shenzhen Future Electronic Co., Ltd
Date Cleared
2022-03-31
(122 days)
Product Code
IRP
Regulation Number
890.5650Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Future Electronic Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Air Compression Therapy Device(model: ST-502) is indicated for the temporary relief of minor muscle aches and pains and for temporary increase in circulation to the treated areas in good health. The Air Compression Therapy Device (model: ST-502) simulates kneading and stroking of tissues by using an inflatable garment.
Device Description
Air Compression Therapy Device, model: ST-502 is a powered inflatable tube massager. The Air Compression Therapy Device, model: ST-502 is consists of an air pump, air pressure sensor, leg sleeves and adapter. The air pump, air pressure sensor and control components are protectively housed in a plastic case of the control unit. The control unit is connected to the dedicated leg sleeves via a series of hoses; each leg sleeve has 3 compression chambers. The Air Compression Therapy Device, model: ST-502 utilizes the pneumatically controlled leg sleeves actuated by an electronically controlled air pump unit.
The "Power" button, "Intensity" button, "Mode" button and LED indicators/displays provide for user interface. There is also a port for connecting the AC adapter plug.
The leg sleeves consist of air pipes and three airbags encased inside a soft medical fabric for increased patient comfort and biocompatibility compliance.
In operation, the user simply turns the power on via the "Power" button. And the user presses the "Intensity" button, "Mode" button to adjust the pressure intensity and working mode of the device as the needs of users.
The compression massage direction is from foot room and push up the thighs. By inflating the air chambers sequentially and then deflating as one cycle, the pressure can be adjusted to avoid any discomfort to the patient. The leg sleeves work under the action of sensor and microprocessor. Software controls the timing and pressure reflected by the sensor, cycling airflow into and out of the sleeves to compress body.
During in the working condition, once the leg sleeves pressure of the airbags reach the proper level(240mmHg), the device is turned off, and the leg sleeves deflates to the ambient pressure through a valve inside the plastic case.
Ask a Question
Page 1 of 1