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510(k) Data Aggregation
K Number
K153045Device Name
SunStim Peripheral Nerve Stimulator/Sunstim Plus Peripheral Nerve Stimulator
Manufacturer
EASYMED INSTRUMENT CO., LTD.
Date Cleared
2016-05-13
(207 days)
Product Code
BXN
Regulation Number
868.2775Why did this record match?
Applicant Name (Manufacturer) :
EASYMED INSTRUMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SunStim Peripheral Nerve Stimulator and SunStim Plus Peripheral Nerve Stimulator are a battery-powered device intended for monitoring the magnitude of neuromuscular block in general anesthesia, by delivering an electrical stimulus near a peripheral motor nerve.
Device Description
SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator are battery powered peripheral nerve stimulators which provide low electrical direct current (DC) stimulation in order to determine the level of anesthetic nerve block. The Stimulus Amplitude control dial provides variable current control (0 to 70 mA into a 2K ohm load).
The Output Stimulus Pulse Indicator flashes each time current passes through the patient. Functions include: Double Burst (DBS), Train-of-Four, Twitch, and 100Hz Tetanus. The device offers sufficient output to ensure supramaximal stimulation: from 0 to 70 mA. SunStim™ Peripheral Nerve Stimulator and SunStim™ Plus Peripheral Nerve Stimulator models have the same functions with the following exceptions: the SunStim™ Peripheral Nerve Stimulator functions do not include Double Burst and the 50 Hz Tetanus option.
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K Number
K143430Device Name
SmartTENS
Manufacturer
EASYMED INSTRUMENT CO., LTD.
Date Cleared
2015-05-29
(179 days)
Product Code
NUH, GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
EASYMED INSTRUMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
Device Description
SmartTENS is a portable battery powered T.E.N.S. device with a wireless remote control feature for over-the-counter use, mainly operating in home, clinic, or hospital environments.
There are three control buttons on the unit itself: ON/OFF, intensity UP and intensity DOWM. The device is also designed to be controlled wirelessly through Bluetooth 4.0 connection (Frequency: 2402.0 - 2480.0 MHz) by a matched smart phone, which is featuring a mobile application (App) developed by EasyMed Instruments Co., Ltd.
A user entered 6-digit security code ensures the access to the device can only be the user's matched smart phone, thus avoiding unauthorized controls to the device.
There are totally seven (7) modes that are intended for pain relieving treatments to the following areas: Shoulder/ Arm, Lower Back and Leg/Foot. The specifications of each mode will be described in greater details in the User Manual.
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K Number
K050921Device Name
EASYSTIM NMS-28
Manufacturer
EASYMED INSTRUMENT CO., LTD.
Date Cleared
2005-12-12
(243 days)
Product Code
IPF, GZJ
Regulation Number
890.5850Why did this record match?
Applicant Name (Manufacturer) :
EASYMED INSTRUMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS stands for Transcutaneous Electrical Nerve Stimulation. This TENS system is used to provide symptomatic pain relief for chronic, acute or post operative pain.
PMS/EMS stands for Powered Muscles Stimulator/Electrical Muscles Stimulator. This PMS/EMS system is indicated for:
- Relaxation of muscle spasm
- Increasing local blood circulation
- Muscle re-education
- Prevention or retardation of disuse atrophy
- Prevention of venous thrombosis of the calf muscles immediately after surgery
- Maintaining or increasing range of motion
Device Description
For the TENS function A portable TENS device for pain relief.
For the EMS function A portable EMS device for the re-education of muscles.
Features:
· Innovative design
· Large LCD display
• Dual output channels
• 2 AA Alkaline Batteries
· Adjustable frequency, pulse width, and timing parameters
• 9 different modes
• Timer option
• Doctor lock/unlock facility
· Open circuit detectors
• Non-volatile
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K Number
K040253Device Name
EASY MED TN-28 C
Manufacturer
EASYMED INSTRUMENT CO., LTD.
Date Cleared
2004-04-08
(64 days)
Product Code
GZJ
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
EASYMED INSTRUMENT CO., LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
Device Description
T.E.N.S. stands for Transcutaneous Electrical Nerve Stimulation. This T.E.N.S. system is used to provide symptomatic pain relief for chronic, acute or post-operative pain.
We do not feel pain until a coded message travels to the brain where it is decoded, analyzed and responded to. The pain message travels from the affected area along small nerve fibers leading into the spinal cord. Here the message is relayed to different nerves that travel up the spinal cord to the brain.
The kind provided to you by your personal Transcutaneous Electrical Nerve Stimulator, TN-28C T.E.N.S. Unit consists of sending small electrical pulses through the skin to the body's nervous system. According to the " gate " theory for pain control, the stimulation of large nerve fibers may result in the blocking of pain transmission.
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