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510(k) Data Aggregation
K Number
K212184Device Name
TENS and EMS Stimulation (OTC)
Manufacturer
Date Cleared
2022-04-01
(262 days)
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Changsha Yuwen Medical Equipment Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
TENS mode: It is used for temporary relief of pain associated with sore and aching muscles in the neck, joint, hip, hand, abdomen, upper extremities (arm) and lower extremities (leg) due to strain from exercise or normal household work activities. EMS mode: This mode is designed to be used for stimulate healthy muscles in order to improve and facilitate muscle performance.
Device Description
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