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510(k) Data Aggregation
K Number
K230443Device Name
TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)
Manufacturer
Jiangxi Royall Smart Technology Co., Ltd.
Date Cleared
2023-05-22
(90 days)
Product Code
NUH, NGX, NYN
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Jiangxi Royall Smart Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
TENS & EMS Device (Model: LY-ET-01, LY-ET-02, LY-ET-04):
- To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve. To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
- To stimulate healthy muscles in order to improve and facilitate muscle performance .
- To temporarily increase local blood circulation in healthy muscles.
Device Description
TENS & EMS Device is a pain management device with a combination of TENS and EMS therapy technology.
It can stimulate healthy muscles in order to improve and facilitate muscle performance, and temporary relief of pain associated with sore and aching muscles in the upper and lower back, back of the neck, upper extremities (shoulder and arm), lower extremities (leg and feet) due to strain from exercise or normal household work activities by applying current to stimulate nerve.
TENS & EMS Device (Model: LY-ET-01, LY-ET-04) has 3 modes (Model LY-ET-02 has 5 modes) and one channel, which provide electrical pulse stimulation through the electrode pads to the treatment area. The TENS & EMS Device has the operating elements of ON/OFF knob, Mode Selection button, Intensity adjustment Dial (or Intensity Increase button and Intensity decrease button) and Time Selection button which is user-friendly and easy to control.
The device is equipped with electrode pads and electrode wire is used to connect the pads to the main unit. All the accessories can only be purchased by a local distributor.
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