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Levina Pelvic Floor Muscle Stimulator (RS-48)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241862
510(k) Type
Traditional
Applicant
ZMI Electronics Ltd.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
3/27/2025
Days to Decision
273 days
Submission Type
Summary

Levina Pelvic Floor Muscle Stimulator (RS-48)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K241862
510(k) Type
Traditional
Applicant
ZMI Electronics Ltd.
Country
Taiwan
FDA Decision
Substantially Equivalent
Decision Date
3/27/2025
Days to Decision
273 days
Submission Type
Summary