Search Results
Found 3 results
510(k) Data Aggregation
K Number
K230164Device Name
TENS and EMS Stimulation (OTC)
Manufacturer
Date Cleared
2023-04-10
(80 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: 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: To be used for stimulation healthy muscles in order to improve or facilitate muscle performance.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
K Number
K230163Device Name
TENS and EMS Stimulation (OTC)
Manufacturer
Date Cleared
2023-03-20
(59 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: 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: To be used for stimulation healthy muscles in order to improve or facilitate muscle performance.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
K Number
K230174Device Name
TENS and EMS Stimulation (OTC)
Manufacturer
Date Cleared
2023-03-20
(59 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: 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: To be used for stimulation healthy muscles in order to improve or facilitate muscle performance.
Device Description
Not Found
Ask a Question
Ask a specific question about this device
Page 1 of 1