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K Number
K955589
Device Name
FERTICARE PERSONAL THERAPEUTIC VIBRATOR
Manufacturer
MULTICEPT APS
Date Cleared
1996-04-11

(126 days)

Product Code
KXQ
Regulation Number
884.5960
Type
Traditional
Panel
OB
Reference & Predicate Devices
N/A
Predicate For
K110566
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 884.5960 Genital vibrator for therapeutic use.

(a)
Identification. A genital vibrator for therapeutic use is an electrically operated device intended and labeled for therapeutic use in the treatment of sexual dysfunction or as an adjunct to Kegel's exercise (tightening of the muscles of the pelvic floor to increase muscle tone).(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E, of this chapter subject to the limitations in § 884.9.