Cleared Traditional

K193364 - Intimate Rose Kegel Exercise System

K193364 is an FDA 510(k) clearance for Intimate Rose Kegel Exercise System, manufactured by Plus EV Holdings Dba Intimate Rose. The device is a Class 2 Obstetrics & Gynecology device with product code HIR cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K193364 · Plus EV Holdings Dba Intimate Rose · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2020
Decision
264d
Days
Class 2
Risk

K193364 is an FDA 510(k) clearance for the Intimate Rose Kegel Exercise System. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Plus EV Holdings Dba Intimate Rose (North Kansas City, US). The FDA issued a Cleared decision on August 24, 2020 after a review of 264 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.1425 - 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 Plus EV Holdings Dba Intimate Rose devices

FDA 510(k) Submission Details - K193364

510(k) Number K193364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2019
Decision Date August 24, 2020
Days to Decision 264 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 160d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HIR Device Classification - Class 2, Special Controls

Product Code HIR Perineometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.1425
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.

Regulatory Consultant

Q-Metrics, LLC
Elizabeth Proctor

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HIR Perineometer

All 21
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