Cleared Traditional

K081053 - PIVOT ASSIST

K081053 is an FDA 510(k) clearance for PIVOT ASSIST, manufactured by Pivot Assist, LLC. The device is a Class 2 Physical Medicine device with product code INO cleared through the Traditional 510(k) pathway after a 178-day FDA review.

K081053 · Pivot Assist, LLC · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2008
Decision
178d
Days
Class 2
Risk

K081053 is an FDA 510(k) clearance for the PIVOT ASSIST. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Pivot Assist, LLC (Garfield Hts., US). The FDA issued a Cleared decision on October 9, 2008 after a review of 178 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3110 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all Pivot Assist, LLC devices

FDA 510(k) Submission Details - K081053

510(k) Number K081053 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 2008
Decision Date October 09, 2008
Days to Decision 178 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d slower than avg
Panel avg: 115d · This submission: 178d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

INO Device Classification - Class 2, Special Controls

Product Code INO Chair, Positioning, Electric
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3110
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - INO Chair, Positioning, Electric

All 12
Devices cleared under the same product code (INO) and FDA review panel - the closest regulatory comparables to K081053.
LIFT CHAIR, MODEL T3
K091578 · Pride Mobility Products Corp. · Dec 2009
LIFT CHAIR, MODEL C5
K070950 · Pride Mobility Products Corp. · Apr 2007
EASYSTAND EVOLV
K062402 · Invacare Corp. · Sep 2006
MERITS MODEL E SERIES LIFT CHAIRS
K060212 · Merits Health Products Co., Ltd. · Mar 2006
MEDLINE ELECTRONIC POSITIONING CHAIR
K001937 · Medline Industries, Inc. · Sep 2000
INVACARE LIFT CHAIR
K002171 · Invacare Corp. · Aug 2000