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K Number
DEN000006
Device Name
EROS-CLITORAL THERAPY DEVICE (CTD)
Manufacturer
UROMETRICS, INC.
Date Cleared
2000-04-28

(1 days)

Product Code
NBV
Regulation Number
884.5970
Type
Post-NSE
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 884.5970 Clitoral engorgement device.

(a)
Identification. A clitoral engorgement device is designed to apply a vacuum to the clitoris. It is intended for use in the treatment of female sexual arousal disorder.(b)
Classification. Class II (special controls). The special control is a guidance document entitled: “Guidance for Industry and FDA Reviewers: Class II Special Controls Guidance Document for Clitoral Engorgement Devices.”