Cleared Traditional

K010917 - POWER TILT AND RECLINE SYSTEM

K010917 is an FDA 510(k) clearance for POWER TILT AND RECLINE SYSTEM, manufactured by Sunrise Medical, Inc.. The device is a Class 2 Physical Medicine device with product code ITI cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K010917 · Sunrise Medical, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2001
Decision
49d
Days
Class 2
Risk

K010917 is an FDA 510(k) clearance for the POWER TILT AND RECLINE SYSTEM. Classified as Wheelchair, Powered (product code ITI), Class II - Special Controls.

Submitted by Sunrise Medical, Inc. (Longmont, US). The FDA issued a Cleared decision on May 15, 2001 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3860 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sunrise Medical, Inc. devices

FDA 510(k) Submission Details - K010917

510(k) Number K010917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2001
Decision Date May 15, 2001
Days to Decision 49 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
66d faster than avg
Panel avg: 115d · This submission: 49d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITI Device Classification - Class 2, Special Controls

Product Code ITI Wheelchair, Powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3860
Definition A Powered Wheelchair Is A Battery-operated Device With Wheels That Is Intended For Medical Purposes To Provide Mobility To Persons Restricted To A Sitting Position. Fda Interprets “mobility To Persons Restricted To A Sitting Position” To Mean The Device Type Is Intended To Provide Mobility To Individuals Who Have Mobility Impairments And Require An Assistive Device For Mobility. Note: This Type Of Device Is Not Intended To Climb Stairs (see Product Code: Imk).
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 - ITI Wheelchair, Powered

All 232
Devices cleared under the same product code (ITI) and FDA review panel - the closest regulatory comparables to K010917.
XTERRA GT POWER WHEELCHAIR
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RANGER II M6, MODEL IN-888WNL
K002157 · Invacare Corp. · Aug 2000