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510(k) Data Aggregation
K Number
K150436Device Name
ComboRehab
Manufacturer
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Date Cleared
2015-11-13
(267 days)
Product Code
IMG, GZI, GZJ, HCC, IPF, LIH
Regulation Number
890.5860Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Therapeutic Ultrasound
- Application of therapeutic deep heat for the treatment of selected sub-chronic medical conditions such as:
- 1. Pain relief, muscle spasms and joint contractures.
- 2. Relief of pain, muscle spasms and joint contractures that may be associated with:
- · Adhesive capsulitis
- Bursitis with slight calcification
- · Myositis
- · Soft tissue injuries
- · Shortened tendons due to past injuries and scar tissues
- 3. Relief of sub-chronic, chronic pain and joint contractures resulting from:
- · Capsular tightness
- · Capsular scarring
For TENS, Interferential, premodulated(IFC), NMS and Microcurrent:
- 1. Symptomatic relief of chronic intractable pain
- 2. Post-traumatic acute pain
- 3. Post-surgical acute pain
Additionally for NMS. NMS Burst, Hi-Volt and Russian:
- 1. Relaxation of Muscle spasms
- 2. Prevention or retardation of disuse atrophy
- 3. Increasing local blood circulation
- 4. Muscle re-education
- 5. Maintaining or increasing range of motion
- 6. Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis
For EMG
- To determine the activation timing of muscles for:
- 1. Retaining of muscle activation
- 2. Coordination of muscle activation
An indication of the force produced by muscle for control and maintenance of muscle contractions
- 1. Relaxation muscle training
- 2. Muscle re-education
For EMG triggered Stim
- 1. Stroke rehab by muscle re-education
- 2. Relaxation of muscle spasms
- 3. Prevention or retardation of disuse atrophy
- 4. Increase local blood circulation
- 5. Muscle re-education
- 6. Maintaining or increasing range of motion
For DC Continuous Mode
- Relaxation of muscle spasm 1)
Device Description
ComboRehab is four channels combination unit, can provide muscle stimulation, ultrasound, biofeedback and combination therapy. This product is designed to offer a multiple choices for clinician in one compact and integrated package.
A large control knobs located on the panel, allows clinician very easy to select different therapy mode and set therapeutic parameters. The award winning design offers a 5 inch Touch TFT LCD color display screen that can helps clinician to monitor the treatment information promptly.
In the electrotherapy mode, it's freedom for clinician to select one, two, three or four channels into therapy. A comprehensive set of current waveforms is available, targeting both pain management and muscle stimulation applications; interferential (4-pole), premodulated (2-pole interferential), Russian, NMS (Pulsed mode, burst mode), high volt, TENS, Microcurrent and Direct current.
The Ultrasound mode can be equipped with two applicators, 1cm² and 5cm². The applicators can operate in continuous or pulsed mode at an ultrasound frequency of 1 MHz or 3 MHz.
The EMG mode can provide us detail information about the organ-specific properties of a muscle through surface EMG electrodes. EMG biofeedback activity can couple with triggered electrical muscle stimulation using selected electrotherapy waveforms for the maximum benefit in muscle re-education.
The combination electrotherapy is used for the management of pain and muscle spasm. All functions of 1 or 3 MHz Ultrasound can be combined with Interferrential, Premodulated, Asymmetrical Biphasic. NMS, NMS burst mode, and High Voltage pulsed Current.
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K Number
K141076Device Name
GARMENT ELECTRODES
Manufacturer
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Date Cleared
2014-11-14
(203 days)
Product Code
GXY
Regulation Number
882.1320Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cutaneous Electrodes including Garment electrodes, which are intended to be used with legally marketed electrical stimulating devices such as transcutaneous electrical nerve stimulators or powered muscle stimulators. The cutaneous electrodes will deliver the stimulation signals generated by the body surface with which they are in contact. The Garment electrodes including glove, socks, sleeve, knee belt and back belt which are made up of silver or conductive silicone rubber.
Device Description
Not Found
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K Number
K133965Device Name
OTC EMS STIMULATOR
Manufacturer
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Date Cleared
2014-06-16
(174 days)
Product Code
NGX
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
The OTC EMS stimulator MT1001 is intended to stimulate healthy muscles of the lower extremity in order to temporarily increase local blood circulation and to stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
Not Found
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K Number
K131899Device Name
SW-THERM
Manufacturer
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Date Cleared
2014-03-14
(262 days)
Product Code
IMJ
Regulation Number
890.5290Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SW-Therm, Model ST 1001, is intended to deliver energy in the radio band of 27.12 MHz to provide deep heating therapeatic effects to body tissues. When shortwave diathermy is delivered to the body at intensities capable of generating a deep tissue temperature increase, it can be used to treat selected medical conditions such as:
I ) Relieving pain;
2) Reducing muscle spasm;
3) Increasing range of motion of contracted joints using heat and stretch techniques; and
4) Increasing blood flow to tissues in the treatment area.
Device Description
Not Found
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K Number
K131259Device Name
LASER-STIM
Manufacturer
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Date Cleared
2013-12-27
(239 days)
Product Code
ILY
Regulation Number
890.5500Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Laser-Stim, Model LS2001, is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting relaxation of muscles.
Device Description
Not Found
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K Number
K130802Device Name
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
Manufacturer
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Date Cleared
2013-09-16
(178 days)
Product Code
NUH, NGX
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
MT9001 OTC TENS/EMS stimulator
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.
EMS: The device is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
LT3060 OTC TENS stimulator
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.
Device Description
Not Found
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K Number
K120217Device Name
SONICSTIMU COMBO THERAPEUTIC DEVICE
Manufacturer
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Date Cleared
2012-11-21
(302 days)
Product Code
IMG, GZJ, LIH
Regulation Number
890.5860Why did this record match?
Applicant Name (Manufacturer) :
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Therapeutic Ultrasound: Application of therapeutic deep heat for the treatment of selected sub-chronic and chronic medical conditions such as: Pain relief, muscle spasms and joint contractures. Relief of pain, muscle spasms and joint contractures that may be associated with: Adhesive capsulitis, Bursitis with slight calcification, Myositis, Soft tissue injuries, Shortened tendons due to past injuries and scar tissues. Relief of sub-chronic, chronic pain and joint contractures resulting from: Capsular tightness, Capsular scarring. For TENS, Interferential, premodulated(IFC), NMS and Microcurrent: Symptomatic relief of chronic intractable pain, Post-traumatic acute pain, Post-surgical acute pain. Additionally for EMS, NMS, Hi-Volt and Russian: Relaxation of Muscle spasms, Prevention or retardation of disuse atrophy, Increasing local blood circulation, Muscle re-education, Maintaining or increasing range of motion, Immediate postsurgical stimulation of calf muscles to prevent venous thrombosis.
Device Description
Not Found
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K Number
K100488Device Name
IR EAR/FOREHEAD THERMOMETER MODE DX6635, DX6637, DTH1081
Manufacturer
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Date Cleared
2010-07-22
(153 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 intended for the intermittent measurement and monitoring of human body temperature by consumers in the home.
Device Description
IR Ear/Forehead thermometer, which includes models DX6635, DX6637, TH1081 and TH1091, are a hand-held, reusable, battery operated device that can measures human body temperature by two ways:
- On forehead, the skin temperature on people's forehead
- In ear, the tymperature in people's ear
The working principle based on infrared sensor technology. It utilizes infrared technology to receive infrared energy emitted from the eardrum or the surface of the object and convert to a voltage. The voltage value is responsible with the different temperature between the target object and infrared sensor. Then MCU will convert this value to digital data by an analog to digital (A/D) circuit. This data will be changed to the finalized temperature data by algorithms and displayed on LCD.
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K Number
K093138Device Name
MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003
Manufacturer
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Date Cleared
2010-02-12
(130 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
MT9000 Combo TENS/EMS/IF/MIC Stimulator:
For TENS 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 muscles to prevent venous thrombosis
For IF mode: 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain
For MIC mode: 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain
MT9001 TENS Stimulator: 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain
MT9002 EMS Stimulator: 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
MT9003 IF Stimulator: 1. Symptomatic relief of chronic intractable pain, 2. Post traumatic pain 3. Post surgical pain
MT9004 MICROCURRENT Stimulator: 1. Symptomatic relief of chronic intractable pain. 2. Post traumatic pain 3. Post surgical pain
Device Description
The MT9000 Series Stimulator, which includes models MT9000, MT9001, MT9002, MT9003, MT9004, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes 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 five models MT9000, MT9001, MT9002, MT9003 and MT9004 have the same housing in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular. 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. The device is equipped with a keypad composed of push buttons which are located below the LCD. The function for each button is defined by a symbol on the LCD corresponding to the button immediately below it. The process to set the parameter and attach lead wires to the five models is also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings. The MT9000 Combo TEN/EMS/IF/MIC Stimulator is the combination unit with the TENS, EMS. IF and MICROCURRENT functions, the function can be selected by press buttons. The range of settings is identical to those of MT9001, MT9002, MT9003 and MT9004. The difference on the five units can be identified by the LCD display.
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K Number
K100117Device Name
LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR
Manufacturer
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
Date Cleared
2010-01-29
(14 days)
Product Code
IPF, GZJ
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
LT3000 Combo Stimulator
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
- Increase of blood flow in the treatment area
- Relaxation of muscle spasm
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion.
LT3001 TENS Stimulator
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
LT3002 EMS Stimulator
- Relaxation of muscle spasm.
- Increase of blood flow in the treatment area
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
- Muscle re-education
- Prevention or retardation of disuse atrophy
- Maintaining or increasing range of motion.
Device Description
The LT3000 Series Stimulator, which includes models LT3000, LT3001 and LT3002, are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group through the cable and electrode placed on the skin. The parameters of units are controlled by the rotate buttons. Its intensity level is adjustable according to the needs of patients.
The three models LT3000, LT3001 and LT3002 have the same housing in a molded portable plastic case, an accessible buttons、 switch, and accessible battery storage compartment. The case shape is rectangular. The process to set the parameter and attach lead wires to the three models is also the same except the Housing printing artwork, Mode No & destination.
The LT3000 Combo Stimulator is the combination unit with both TENS and EMS functions, the function can be selected by switch. The range of settings is identical to those of LT3001 and LT3002. The difference on the three units can be identified by printing artwork, Mode No.
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