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510(k) Data Aggregation
K Number
K223428Device Name
Electronic Stimulator (Models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A)
Manufacturer
Date Cleared
2023-05-08
(175 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Leqing Medical Instrument Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Models: uLumb-9530A、uLumb-9531A、uLumb-9532A、uLumb-9533A、LQ-9525B:
Electrical simulation: To be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, back of neck, arm, and leg, due to strain from exercise or normal household and work activities.
Notel : The electrode on the stimulator is used in the waist.
Note2: The additional gel patch is used in shoulder, waist, back, back of neck, arm, and leg,
Heating: To be used for temporary relief of minor aches and pains.
Models: uNeck-9512A, uNeck-9517B, uNeck-9517B, uNeck-9519A, uNeck-9521A, uNeck-9529A, LO-9535 A: Electrical simulation: 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. Heating: To be used for temporary relief of minor aches and pains.
Device Description
The Electronic Stimulator is a portable and battery-powered TENS device with multiple models, offering both electrical pulse stimulation and heating function in one device.
The device consists of a controller that has built-in metal electrodes and accessories of a remote control, an adapter, and/or a pair of gel electrodes, an external connection coupling. The external connection coupling is used to connect the gel electrodes to the device. All models are powered by internal rechargeable battery and charged by the adapter. And all accessories, including the remote control, adapter, gel electrodes, external connection coupling can only be changed or replaced by a qualified person.
The functions of the device are controlled by the device controller and the remote control, where the remote control establishes a connection with the device controller through wireless signals. The device has five stimulation modes and one heating mode, through the metal electrodes to provide users with waist or nape stimulation and heat generation to warm and comfortable waist or nape muscles. And the heating function is controlled by a heat/temperature key and can only be run on metal electrodes, it is cannot be operated alone. The heating temperature does not exceed 43 degrees Celsius at the same time. In addition, the device is also equipped with a pair of gel electrodes, which can be used to stimulate different parts of the body (shoulder, waist, back, back of neck (nape), arm, and leg).
The device has 13 models: uLumb-9530A, uLumb-9531A, uLumb-9532A, uLumb-9533A, LQ-9525B, uNeck-9512A, uNeck-9515A, uNeck-9517B, uNeck-9518A, uNeck-9519A, uNeck-9521A, uNeck-9529A, LQ-9535A, the 13 models differ in appearance, size, battery capacity, number of keys on the stimulator, the specification of electrodes equipped, and some output parameters, the details can refer to the "Model list form" of the Device Description file in this application.
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