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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d slower than avg
Panel avg: 116d · 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 49
Devices cleared under the same product code (INO) and FDA review panel - the closest regulatory comparables to K081053.
BANTAM
K091242 · Altimate Medical, Inc. · Jul 2009
MEDICAL TREATMENT CHAIR, T400, T500,T600
K091727 · Fresenius Medical Care South Asia Pacific Pty , Ltd. · Jul 2009
STANDARD WHEELCHAIR PLATFORM
K073565 · Design Specific , Ltd. · Feb 2009
WINCO MODEL POWER SERIES LIFT CHAIR
K080533 · Winco, Inc. · Aug 2008
CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR
K071793 · Barton Medical Corp. · Aug 2007
LIFT CHAIR, MODEL C5
K070950 · Pride Mobility Products Corp. · Apr 2007
K081053 · PIVOT ASSIST
Download PDF FDA Summary Pivot Assist, LLC