Cleared Traditional

K102734 - COMFORT STANDING WHEELCHAIR, HERO SERIES

K102734 is an FDA 510(k) clearance for COMFORT STANDING WHEELCHAIR, manufactured by Comfort Orthopedic Co., Ltd.. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K102734 · Comfort Orthopedic Co., Ltd. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
83d
Days
Class 2
Risk

K102734 is an FDA 510(k) clearance for the COMFORT STANDING WHEELCHAIR, HERO SERIES. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Comfort Orthopedic Co., Ltd. (Columbus, US). The FDA issued a Cleared decision on December 14, 2010 after a review of 83 days - a notably fast clearance cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3900 - 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.

FDA 510(k) Submission Details - K102734

510(k) Number K102734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2010
Decision Date December 14, 2010
Days to Decision 83 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
33d faster than avg
Panel avg: 116d · This submission: 83d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IPL Device Classification - Class 2, Special Controls

Product Code IPL Wheelchair, Standup
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3900
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 - IPL Wheelchair, Standup

All 54
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K102734.
Tek RMD (Tek Robotic Mobilization Device)
K150548 · Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S · Jun 2015
E-TENG MODEL EOR 1
K122562 · E-Teng Technology, Inc. · Aug 2013
HIROLLER ELEVATING WHEELCHAIR
K102837 · Max Mobility, LLC · Dec 2010
POWER STANDING DANI
K090256 · Davismade, Inc. · Jul 2009
LEVO C3
K083017 · Levo AG · Oct 2008
BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)
K072475 · Etac Sverige AB · Dec 2007
K102734 · COMFORT STANDING WHEELCHAIR, HERO SERIES
Download PDF FDA Summary Comfort Orthopedic Co…