Product Code: IPL FDA class 2 21 CFR 890.3900

Wheelchair, Standup

Physical Medicine

A Standup Wheelchair is a specialized powered or manual wheelchair designed to transition the user from a seated to an upright standing position while remaining in the device, used in Physical Medicine to provide health benefits of standing including bone density maintenance, circulation improvement, and pressure relief, while retaining mobility. It is classified as FDA Class 2, representing moderate risk, meaning it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device before marketing. The product code is IPL, regulated under 21 CFR 890.3900, within the Physical Medicine medical specialty. This device is eligible for third party review, meaning the 510(k) submission may be reviewed by an FDA-accredited third party organization.

View on FDA

510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Research product code IPL in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Ask the Research Assistant See examples

Basic Information

Product Code: IPL
Device Class: FDA class 2
Regulation Number: 890.3900
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 66 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243783	Walking rehabilitation training electric wheelchair (ZW518)	Mar 12, 2025	Substantially Equivalent	Shenzhen Zuowei Technology Co., Ltd.
K202728	Action Trackchair Hawk	Feb 10, 2022	Substantially Equivalent	Action Manufacturing, Inc.
K203761	ParaMotion	Jan 21, 2022	Substantially Equivalent	Powerbasetec GmbH
K191334	Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08	May 29, 2020	Substantially Equivalent	Matia Robotics (Us), Inc.
K190682	Explorer Mini	Feb 27, 2020	Substantially Equivalent	Permobil AB
K191874	F5 Corpus VS	Oct 25, 2019	Substantially Equivalent	Permobil AB
K182257	UPnRIDE	Sep 12, 2019	Substantially Equivalent	Upnride Robotics , Ltd.
K191376	Modular Power Standing System	Aug 13, 2019	Substantially Equivalent	Motion Concepts
K172384	Quickie(r) Q700-UP M	Jan 16, 2018	Substantially Equivalent	Sunrise Medical (Us), LLC
K163451	Action Trackstander models TR1816, TR1820, TR2016, and TR2020	Jan 12, 2018	Substantially Equivalent	Action Manufacturing, Inc.
K150548	Tek RMD (Tek Robotic Mobilization Device)	Jun 11, 2015	Substantially Equivalent	Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S
K122562	E-TENG MODEL EOR 1	Aug 09, 2013	Substantially Equivalent	E-Teng Technology, Inc.
K102837	HIROLLER ELEVATING WHEELCHAIR	Dec 23, 2010	Substantially Equivalent	Max Mobility, LLC
K102734	COMFORT STANDING WHEELCHAIR, HERO SERIES	Dec 14, 2010	Substantially Equivalent	Comfort Orthopedic Co., Ltd.
K090256	POWER STANDING DANI	Jul 06, 2009	Substantially Equivalent	Davismade, Inc.
K083017	LEVO C3	Oct 24, 2008	Substantially Equivalent	Levo AG
K072475	BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)	Dec 21, 2007	Substantially Equivalent	Etac Sverige AB
K071761	LLOYD LINDEN, MODEL E04	Aug 03, 2007	Substantially Equivalent	Lloyd Linden, Inc.
K071390	WHEELCHAIR MODEL STS	Jul 20, 2007	Substantially Equivalent	Innovative Products, Inc.
K061726	LSC, MODEL 3	Dec 04, 2006	Substantially Equivalent	Lifestand
K060936	PARAGOLFER	Aug 07, 2006	Substantially Equivalent	Parabasetec, GmbH
K052375	ALILIFE STAND UP POWERED WHEELCHAIR, HC-300	Sep 09, 2005	Substantially Equivalent	Alilife Technological Co., Ltd.
K051387	LEVO COMFORT II	Jun 10, 2005	Substantially Equivalent	Levo AG
K042596	LSA HELIUM	Jan 26, 2005	Substantially Equivalent	Lifestand
K041535	LSC LIFESTAND COMPACT	Sep 16, 2004	Substantially Equivalent	Lifestand
K032101	POWERSTAND STAND-UP WHEELCHAIR	Jan 22, 2004	Substantially Equivalent	The Standing Co., Inc.
K031621	HERO 1, MODEL LY-ESB220	Jan 22, 2004	Substantially Equivalent	Comfort Orthopedic Co., Ltd.
K031618	COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2	Dec 18, 2003	Substantially Equivalent	Comfort Orthopedic Co., Ltd.
K030882	RABBIT MOBILE STANDING FRAME	Apr 04, 2003	Substantially Equivalent	R82 A/S
K030893	LEVO COMBI	Apr 02, 2003	Substantially Equivalent	Levo AG
K021165	NEW HEIGHTS ELECTRIC ELEVATING POWER WHEELCHAIR MODEL NO. 08 02 SERIES	Jul 01, 2002	Substantially Equivalent	Bromac Assistive Technology
K011530	VERTRAN STANDING WHEELCHAIR	Oct 16, 2001	Substantially Equivalent	Fena Design, Inc.
K012345	NEW HEIGHTS ELECTRIC ELEVATING MANUAL WHEELCHAIR	Oct 03, 2001	Substantially Equivalent	Bromac Assistive Technology
K994083	STANNAH POWER CHAIR, MODEL 201	Apr 04, 2001	Substantially Equivalent	Stannah Power Chairs , Ltd.
K984391	THE LIBERATOR	Sep 03, 1999	Substantially Equivalent	Liberator Wheelchairs, Inc.
K973951	LEVO COMPACT-EASY LCE	Dec 23, 1997	Substantially Equivalent	Levo USA
K963817	LEVO MOBIL LCM	Dec 23, 1997	Substantially Equivalent	Levo USA
K971873	LEVO ACTIVE-EASY LAE	Jul 03, 1997	Substantially Equivalent	Levo USA
K970543	BOBCAT DX	Jun 26, 1997	Substantially Equivalent	Quest Enabling Designs , Ltd.
K963816	LEVO COMPACT LC	Oct 30, 1996	Substantially Equivalent	Levo USA
K962278	SUPERSTAND STAND-UP WHELLCHAIR	Oct 02, 1996	Substantially Equivalent	The Standing Co., Inc.
K940919	CHIEF SR	Feb 03, 1995	Substantially Equivalent for Some Indications	Redman, Inc.
K940852	CHIEF STANDUP WHEELCHAIR	Feb 03, 1995	Substantially Equivalent for Some Indications	Redman, Inc.
K946110	REGAIN STAND-UP WHEELCHAIR	Feb 01, 1995	Substantially Equivalent	Regain, Inc.
K943129	ECONOSTAND	Nov 17, 1994	Substantially Equivalent for Some Indications	Sf Research Corp.
K943337	STANDUP WHEELCHAIR	Aug 09, 1994	Substantially Equivalent	Nestor Rehab Products , Ltd.
K924314	MOBILE STANDING FRAME	Feb 12, 1993	Substantially Equivalent	Metatech Corp.
K922107	TAYLOR MADE MOBILE STANDER	May 26, 1992	Substantially Equivalent	Nelson A. Taylor Co., Inc.
K921894	RIFTON MOBILE PRONE STANDERS	May 26, 1992	Substantially Equivalent	Rifton Equipment For the Handicapped
K921084	THE EXCELSIOR	Apr 07, 1992	Substantially Equivalent	Rehab Technology, Inc.
K920463	ZIPPIE 3 TS/SP WHEELCHAIR/STANDER	Apr 02, 1992	Substantially Equivalent	Sunrise Medical Quickie Designs, Inc.
K911608	GRANSTAND	Apr 23, 1991	Substantially Equivalent	Prime Engineering
K896904	B.A.C. 3000 CHAIR/STANDER	Jan 03, 1990	Substantially Equivalent	Luconex, Inc.
K895686	DAILY ACTIVITY ASSIST DEVICE (MOBILE STANDING AID)	Nov 08, 1989	Substantially Equivalent	Stand-N-Go Corp.
K890695	HI-RIDER WHEELCHAIR	Apr 10, 1989	Substantially Equivalent	Retec USA, Inc.
K890602	STANDING DANI WHEELSTAND	Mar 23, 1989	Substantially Equivalent	Davis Positioning Systems, Inc.
K884840	B.A.C. 1000 MOBILE STANDING DEVICE	Mar 15, 1989	Substantially Equivalent	Luconex, Inc.
K884541	PRO-VERTIC 2000 STAND-UP/SELF-RISING WHEELCHAIR	Nov 23, 1988	Substantially Equivalent	Pro-Vertic, Inc.
K872934	STAND AID	Nov 23, 1987	Substantially Equivalent	Stand Aid of Iowa, Inc.
K863118	I.D.C. STANDUP WHEELCHAIRS	Aug 21, 1986	Substantially Equivalent	Intl. Diffusion Consommateur
K862305	ARISE, VIVRE DEBOUT	Jul 09, 1986	Substantially Equivalent	Natco Corp.
K862013	STANDING WHEELER	Jul 08, 1986	Substantially Equivalent	Engineering Mechanics, Co.
K841920	MAC-MULTI-ADJUSTABLE CHAIR	May 23, 1984	Substantially Equivalent	Alpha Unlimited, Inc.
K840626	VERTICALIBRE WHEELCHAIR	Feb 27, 1984	Substantially Equivalent	Poirier S.A.
K832696	RISER STANDUP WHEELCHAIR	Sep 20, 1983	Substantially Equivalent	Imex Medical Systems, Inc.
K790265	LEVO-STAND-UP WHEELCHAIR	Feb 13, 1979	Substantially Equivalent	Marion Laboratories, Inc.