Cleared Special

K070950 - LIFT CHAIR, MODEL C5

K070950 is an FDA 510(k) clearance for LIFT CHAIR, manufactured by Pride Mobility Products Corp.. The device is a Class 2 Physical Medicine device with product code INO cleared through the Special 510(k) pathway after a 12-day FDA review.

K070950 · Pride Mobility Products Corp. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
12d
Days
Class 2
Risk

K070950 is an FDA 510(k) clearance for the LIFT CHAIR, MODEL C5. Classified as Chair, Positioning, Electric (product code INO), Class II - Special Controls.

Submitted by Pride Mobility Products Corp. (Exeter, US). The FDA issued a Cleared decision on April 16, 2007 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3110 - the FDA physical medicine device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Pride Mobility Products Corp. devices

FDA 510(k) Submission Details - K070950

510(k) Number K070950 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 2007
Decision Date April 16, 2007
Days to Decision 12 days
Submission Type Special
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
104d faster than avg
Panel avg: 116d · This submission: 12d
Pathway characteristics
Modification to existing cleared device.

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 29
Devices cleared under the same product code (INO) and FDA review panel - the closest regulatory comparables to K070950.
PIVOT ASSIST
K081053 · Pivot Assist, LLC · Oct 2008
WINCO MODEL POWER SERIES LIFT CHAIR
K080533 · Winco, Inc. · Aug 2008
CONVERTIBLE I-SERIES POSITIONING AND TRANSFER CHAIR
K071793 · Barton Medical Corp. · Aug 2007
EASYSTAND EVOLV
K062402 · Invacare Corp. · Sep 2006
MERITS MODEL E SERIES LIFT CHAIRS
K060212 · Merits Health Products Co., Ltd. · Mar 2006
AEROLET TOILET LIFT, MODEL AER-01
K031045 · Economic Holland B.V. · Jul 2003