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510(k) Data Aggregation
K Number
K213741Device Name
TENS & EMS DEVICE (Model: FM-B2403A)
Manufacturer
Date Cleared
2022-03-08
(99 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jianfeng Electronic Technology Co. Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities. EMS: The device is designed to be used to stimulate healthy muscles in order to improve or facilitate muscle performance.
Device Description
The device of the model FM-B2403A is a portable, battery powered (lithium battery 3.7V DC) multifunction device offering both Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) qualities in one device, it can be used for arm, shoulder, neck, back, waist, abdomen, and leg. 4 channels that effectively transfer your desired choice of programmed electrical pulses directly through electrode adhesive pads to the suggested area of the body where the electrodes are placed, causing minimal muscle contractions. There are 24 modes of operations.
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