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510(k) Data Aggregation
K Number
K223825Device Name
Tens & Ems Device
Date Cleared
2023-05-09
(139 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Jian Feng 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
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