Cleared Traditional

FERTICARE PERSONAL THERAPEUTIC VIBRATOR (K955589) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K955589 · Multicept, Aps. · Obstetrics & Gynecology device
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Apr 1996
Decision
126d
Days
Class 2
Risk

K955589 is an FDA 510(k) clearance for the FERTICARE PERSONAL THERAPEUTIC VIBRATOR. Classified as Vibrator For Therapeutic Use, Genital (product code KXQ), Class II - Special Controls.

Submitted by Multicept, Aps. (2960 Rungsted Kyst,Denmark, DK). The FDA issued a Cleared decision on April 11, 1996 after a review of 126 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.5960 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Multicept, Aps. devices

Submission Details

510(k) Number K955589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1995
Decision Date April 11, 1996
Days to Decision 126 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 160d · This submission: 126d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KXQ Vibrator For Therapeutic Use, Genital
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.5960
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.