Cleared Traditional

K021165 - NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES

K021165 is an FDA 510(k) clearance for NEW HEIGHTS ELECTRIC ELEVATING POWER WH..., manufactured by Bromac Assistive Technology. The device is a Class 2 Physical Medicine device with product code IPL cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K021165 · Bromac Assistive Technology · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
81d
Days
Class 2
Risk

K021165 is an FDA 510(k) clearance for the NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES. Classified as Wheelchair, Standup (product code IPL), Class II - Special Controls.

Submitted by Bromac Assistive Technology (Lancaster, US). The FDA issued a Cleared decision on July 1, 2002 after a review of 81 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.

View all Bromac Assistive Technology devices

FDA 510(k) Submission Details - K021165

510(k) Number K021165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 11, 2002
Decision Date July 01, 2002
Days to Decision 81 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 115d · This submission: 81d
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 25
Devices cleared under the same product code (IPL) and FDA review panel - the closest regulatory comparables to K021165.
Action Trackstander models TR1816, TR1820, TR2016, and TR2020
K163451 · Action Manufacturing, Inc. · Jan 2018
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
STANNAH POWER CHAIR, MODEL 201
K994083 · Stannah Power Chairs , Ltd. · Apr 2001
THE LIBERATOR
K984391 · Liberator Wheelchairs, Inc. · Sep 1999
LEVO MOBIL LCM
K963817 · Levo USA · Dec 1997