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510(k) Data Aggregation
K Number
K220005Device Name
TENS & PMS Unit
Manufacturer
Date Cleared
2022-04-01
(87 days)
Product Code
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Shenzhen Yuehua Xinsen Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TENS (1,2,5,8,9,10,14,15,17,18,21,22,23): 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. PMS (3,4,6,7,11,12,13,16,19,20,24): It is intended to be used to stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
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