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Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240805
510(k) Type
Traditional
Applicant
Pelvital USA, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/1/2024
Days to Decision
129 days
Submission Type
Summary

Flyte Mechanotherapy System, MTI-1.5 (MTI-1.5)

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K240805
510(k) Type
Traditional
Applicant
Pelvital USA, Inc.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
8/1/2024
Days to Decision
129 days
Submission Type
Summary