Cleared Traditional

K133990 - IEVA REHABILITATIVE POSITIONAL DEVICE

K133990 is an FDA 510(k) clearance for IEVA REHABILITATIVE POSITIONAL DEVICE, manufactured by Remendium Labs, LLC. The device is a Class 2 Gastroenterology & Urology device with product code HIR cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K133990 · Remendium Labs, LLC · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2014
Decision
286d
Days
Class 2
Risk

K133990 is an FDA 510(k) clearance for the IEVA REHABILITATIVE POSITIONAL DEVICE. Classified as Perineometer (product code HIR), Class II - Special Controls.

Submitted by Remendium Labs, LLC (Baton Rouge, US). The FDA issued a Cleared decision on October 9, 2014 after a review of 286 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 884.1425 - the FDA gastroenterology and urology 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 Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Remendium Labs, LLC devices

FDA 510(k) Submission Details - K133990

510(k) Number K133990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2013
Decision Date October 09, 2014
Days to Decision 286 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
156d slower than avg
Panel avg: 130d · This submission: 286d
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - HIR Perineometer

All 22
Devices cleared under the same product code (HIR) and FDA review panel - the closest regulatory comparables to K133990.
Pelvital System
K200409 · Pelvital USA, Inc. · Jul 2020
LEva Pelvic Digital Health System
K192270 · Renovia, Inc. · Nov 2019
leva Pelvic Floor Trainer
K180637 · Renovia, Inc. · Apr 2018
INCARE PELVIC FLOOR THERAPY SYSTEM
K013612 · Hollister, Inc. · Mar 2002
INCARE PRESSURE BIOFEEDBACK VAGINAL PRESSURE PROBE AND ANAL PRESSURE PROBE
K013653 · Hollister, Inc. · Mar 2002
PERINEOMETER & VAGINAL PROBE (BIOFEEDBACK MONITOR #20 AND VAGINAL PROBE)
K970145 · Biosearch Medical Products, Inc. · Aug 1997