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TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230443
510(k) Type
Traditional
Applicant
Jiangxi Royall Smart Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
5/22/2023
Days to Decision
90 days
Submission Type
Summary

TENS & EMS Device (LY-ET-01, LY-ET-02, LY-ET-04)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K230443
510(k) Type
Traditional
Applicant
Jiangxi Royall Smart Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
5/22/2023
Days to Decision
90 days
Submission Type
Summary