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TENS and EMS Stimulation (OTC)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230164
510(k) Type
Traditional
Applicant
Changsha Yuwen Medical Equipment Co., Ltd
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/10/2023
Days to Decision
80 days
Submission Type
Statement

TENS and EMS Stimulation (OTC)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230164
510(k) Type
Traditional
Applicant
Changsha Yuwen Medical Equipment Co., Ltd
Country
China
FDA Decision
Substantially Equivalent
Decision Date
4/10/2023
Days to Decision
80 days
Submission Type
Statement