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510(k) Data Aggregation
K Number
K240358Device Name
ShockPhysio Mobile (model SW3200 Basic)
Manufacturer
Shenzhen Dongdixin Technology Co., Ltd.
Date Cleared
2024-06-05
(120 days)
Product Code
ISA
Regulation Number
890.5660Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Dongdixin Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ShockPhysio Mobile (model SW3200 Basic) is indicated for:
- Relief of minor muscle aches and pains
- Temporary increase in local blood circulation
- Activation of connective tissue
Device Description
Not Found
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K Number
K213043Device Name
Levator Elite (Model LE9011)
Manufacturer
Shenzhen Dongdixin Technology Co., Ltd.
Date Cleared
2022-02-25
(156 days)
Product Code
IPF, GZJ, HCC, KPI
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Dongdixin Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
NMES 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
EMG Triggered Stimulation (ETS) (nonimplanted electrical continence device only) Acute and ongoing treatment of stress, urge or mixed urinary incontinence and where the following results may improve urinary control: Inhibition of the detrusor muscles through reflexive mechanisms of pelvic floor muscles Incontinence treatment for assessing EMG activity of the pelvic floor and accessory muscles (abdominal or gluteal)
TENS Symptomatic relief and management of chronic (long-term), intractable pain Adjunctive treatment in the management of post-surgical pain and post traumatic acute pain
EMG Biofeedback, relaxation muscle training and muscle re-education
Device Description
Levator Elite(Model LE9011) is a single channel, hand-held, non-sterile, battery-powered, multi-patient device intended to be used by adult patients under the supervision of a trained clinical healthcare provider. The device contains EMG biofeedback, TENS (Transcutaneous Electrical Nerve Stimulation), ETS (EMG triggered stimulation) and NMES (Neuromuscular Electrical Stimulator). Each of them has pre-set and custom programs. The parameters of the device are controlled by the buttons, the levels of intensity are adjustable to the needs of the patient and treatments prescribed by their healthcare providers.
The device is designed to provide safe and effective electrical stimulation by sending small electrical currents to underlying nerves and muscle groups via electrode pads applied on the skin or through a vaginal probe/rectal probe (for incontinence treatment protocols only). It can be used with or without linkage to a PC. Connecting the device with the PC via USB cable, the data can be transmitted between PC and device (It needs purchase the PC software Nu-Tek System and USB connection cable).
For EMG biofeedback, EMG is for detecting the signal of muscle, which display muscle strength via EMG biofeedback bar graph or waveform format viewed on the LCD screen of the unit. Surface EMG is used for recording from superficial muscles in clinical or kinesiological protocols, where intramuscular electrodes are used for investigating deep muscles or localized muscle activity.
For NMES is the elicitation of muscle contraction using electric impulses. The impulses are generated by a device and delivered through the electrodes in direct proximity to the muscles to be stimulated or via the probe. The impulses mimic the action potential coming from the central nervous system, causing the muscles to contract. NMES is both a form of electrotherapy and of muscle training. Neuromuscular Stimulation has been used to stimulate muscle and nerve fibers for muscle strengthening, maintenance of muscle mass and strength during prolonged periods of immobilization, selective muscle retraining.
For ETS (i.e. EMG triggered stimulation), ETS involves initiating a voluntary contraction for a specific movement until the muscle activity reaches a threshold level. As soon as the EMG activity reaches a target threshold then an assisting electrical stimulus begins which helps to support the contracted muscle. A microprocessor connected to the surface electrodes, vaginal probe or rectal probe monitors the EMG activity levels as well as administers the neuromuscular stimulation. The target threshold could be set to automated regime, when it goes up and down depending on the running muscle performance.
For TENS, the device provides a non-invasive, low-risk nerve stimulation in order to reduce pain (both acute and chronic). In TENS, mild electrical impulses are transmitted through the skin via surface electrodes to relieve muscle pain by modifying the body's pain perception. TENS does not cure problematic physiological conditions: it only helps to control the pain perception.
LE9011 consists of the following elements:
- Main device
- Pedestal
- Lead wire
- Electrode pad
- Vaginal probe
- Rectal probe (optional)
- PC Software(optional)
- USB Cable(optional)
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K Number
K210364Device Name
Migraine Tens Digital Pain Reliever
Manufacturer
Shenzhen Dongdixin Technology Co., Ltd.
Date Cleared
2021-06-17
(129 days)
Product Code
PCC
Regulation Number
882.5891Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Dongdixin Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Migraine TENS Digital Pain Reliever LT1103
- The acute treatment of migraine with or without aura in patients 18 years of age or older.
- The prophylactic treatment of episodic migraine in patients 18 years of age or older.
Migraine TENS Digital Pain Reliever LT1103-P
- The prophylactic treatment of episodic migraine in patients 18 years of age or older.
Device Description
The Migraine TENS Digital Pain Reliever is a neurostimulator that is applied to the forehead using a self-adhesive electrode positioned bilaterally over the supratrochlearis and supraorbitalis nerves. Supratrochlearis and supraorbitalis (or supratrochlear and supraorbital) nerves belong to the upper branch of the trigeminal nerve (V1). The device uses electric impulses that are delivered to the supratrochlearis and supraorbitalis nerves to prevent and treat pain in the head area.
The Migraine TENS Digital Pain Reliever is operated by a rechargeable battery. Pressure on the single button allows selecting and starting a stimulation program, which runs automatically. And during ramping up, users could choose comfortable intensity level by pressing the button to lock up the current intensity.
The Migraine TENS Digital Pain Reliever consists of the following elements:
- Main Device
- Charging Station
- Electrode Pads
- USB cable
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K Number
K171978Device Name
Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10
Manufacturer
Shenzhen Dongdixin Technology Co., Ltd.
Date Cleared
2017-10-02
(94 days)
Product Code
IPF, GZJ, LIH
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Dongdixin Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Combo Stimulator MT9000
For TENS/IF/MIC mode
1. Symptomatic relief of chronic intractable pain
2. Post traumatic pain
3. Post surgical pain
For EMS mode
1. Relaxation of muscle spasm.
2. Increase of local blood flow circulation
3. Prevention or retardation of disuse atrophy
4. Muscle re-education
5. Maintaining or increasing range of motion.
6. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Combo Stimulator LT7102
For TENS/IF/MIC mode
1. Symptomatic relief of chronic intractable pain
2. Post traumatic pain
3. Post surgical pain
For EMS/RUSS mode
1. Relaxation of muscle spasm.
2. Increase of local blood flow circulation
3. Prevention or retardation of disuse atrophy
4. Muscle re-education
5. Maintaining or increasing range of motion.
6. Immediate post-surgical stimulation of muscles to prevent venous thrombosis
TENS Stimulator Intensity 10
1. Symptomatic relief of chronic intractable pain
2. Post traumatic pain
3. Post surgical pain
Device Description
MT9000, LT7102 and Intensity 10 are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator sends gentle electrical current to underlying nerves and muscle group via electrode applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
The 3 models MT9000, LT7102 and Intensity 10 have similar housing with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user.
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K Number
K162479Device Name
Smart Pain Reliever, Model LT5019
Manufacturer
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
Date Cleared
2017-02-08
(155 days)
Product Code
NUH, NGX, NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS: The device is designed to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities(arm) and lower extremities (leg) due to strain from exercise or normal household work activities. And to be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
LT5019 is designed to be used at home, by adults of all genders. The Smart Pain Reliever includes TENS, EMS (including MASSAGE Program). Transcutaneous Electrical Nerve Stimulation (TENS) is a noninvasive, drug free method of controlling pain. EMS works by sending electronic pulses to the muscle needing treatment; this causes the muscle to exercise passively. The Smart Pain Reliever device is controlled by means of an APP on a mobile device (phone or table). The communication is done via Bluetooth Low Energy. The APP operates on IOS and Android platforms (IOS 8.0 or greater, Android 5.0 or greater).
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K Number
K161735Device Name
Non-contact Forehead Thermometer
Manufacturer
Shenzhen Dongdixin Technology Co., Ltd.
Date Cleared
2016-11-17
(147 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Dongdixin Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Non-contact Forehead Thermometer is a non-sterile, reusable clinical thermometer intended for the intermittent determination of human body temperature in a touch mode on the centre of the forehead as the measurement site on people of all ages.
Device Description
The Non-contact Forehead Thermometer (Model TH1009N) is a hand-held, battery powered device designed to measure human body temperature. The TH1009N is a kind of medical device that utilize infrared radiation to measure body temperature. The Non-contact Forehead Thermometer is intended to measure forehead temperature.
The Non-contact Forehead Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, and an infrared distance sensor for detection of contact or non-contact (at a distance of approximately 0-5cm) use and compensation of the temperature reading.
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K Number
K110707Device Name
CARE BACK PAIN RELIEF STIMULATOR; CARE BACK PAIN RELIEF STIMULATOR
Manufacturer
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
Date Cleared
2011-08-03
(142 days)
Product Code
NUH
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K051251Device Name
INFRARED EAR THEMOMETER, MODELS DX6603, DX66390
Manufacturer
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
Date Cleared
2005-09-07
(114 days)
Product Code
FLL
Regulation Number
880.2910Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN DONGDIXIN TECHNOLOGY CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is an electronic clinical thermometer using an infrared sensor to detect body temperature from the auditory canal in neonatal, pediatric and adult population used in the home setting.
Device Description
The device is an electronic clinical thermometer using an infrared sensor.
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