IPL · Class II · 21 CFR 890.3900

FDA Product Code IPL: Wheelchair, Standup

Leading manufacturers include Levo USA, Lifestand and Levo AG.

66
Total
66
Cleared
134d
Avg days
1979
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times improving: avg 93d recently vs 134d historically

FDA 510(k) Cleared Wheelchair, Standup Devices (Product Code IPL)

66 devices
1–24 of 66
Cleared Mar 12, 2025
Walking rehabilitation training electric wheelchair (ZW518)
K243783
Shenzhen Zuowei Technology Co., Ltd.
Physical Medicine · 93d
Cleared Feb 10, 2022
Action Trackchair Hawk
K202728
Action Manufacturing, Inc.
Physical Medicine · 510d
Cleared Jan 21, 2022
ParaMotion
K203761
Powerbasetec GmbH
Physical Medicine · 394d
Cleared May 29, 2020
Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08
K191334
Matia Robotics (Us), Inc.
Physical Medicine · 378d
Cleared Feb 27, 2020
Explorer Mini
K190682
Permobil AB
Physical Medicine · 346d
Cleared Oct 25, 2019
F5 Corpus VS
K191874
Permobil AB
Physical Medicine · 105d
Cleared Sep 12, 2019
UPnRIDE
K182257
Upnride Robotics , Ltd.
Physical Medicine · 387d
Cleared Aug 13, 2019
Modular Power Standing System
K191376
Motion Concepts
Physical Medicine · 82d
Cleared Jan 16, 2018
Quickie(r) Q700-UP M
K172384
Sunrise Medical (Us), LLC
Physical Medicine · 161d
Cleared Jan 12, 2018
Action Trackstander models TR1816, TR1820, TR2016, and TR2020
K163451
Action Manufacturing, Inc.
Physical Medicine · 400d
Cleared Jun 11, 2015
Tek RMD (Tek Robotic Mobilization Device)
K150548
Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S
Physical Medicine · 100d
Cleared Aug 09, 2013
E-TENG MODEL EOR 1
K122562
E-Teng Technology, Inc.
Physical Medicine · 352d
Cleared Dec 23, 2010
HIROLLER ELEVATING WHEELCHAIR
K102837
Max Mobility, LLC
Physical Medicine · 85d
Cleared Dec 14, 2010
COMFORT STANDING WHEELCHAIR, HERO SERIES
K102734
Comfort Orthopedic Co., Ltd.
Physical Medicine · 83d
Cleared Jul 06, 2009
POWER STANDING DANI
K090256
Davismade, Inc.
Physical Medicine · 154d
Cleared Oct 24, 2008
LEVO C3
K083017
Levo AG
Physical Medicine · 15d
Cleared Dec 21, 2007
BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION)
K072475
Etac Sverige AB
Physical Medicine · 108d
Cleared Aug 03, 2007
LLOYD LINDEN, MODEL E04
K071761
Lloyd Linden, Inc.
Physical Medicine · 35d
Cleared Jul 20, 2007
WHEELCHAIR MODEL STS
K071390
Innovative Products, Inc.
Physical Medicine · 63d
Cleared Dec 04, 2006
LSC, MODEL 3
K061726
Lifestand
Physical Medicine · 168d
Cleared Aug 07, 2006
PARAGOLFER
K060936
Parabasetec, GmbH
Physical Medicine · 124d
Cleared Sep 09, 2005
ALILIFE STAND UP POWERED WHEELCHAIR, HC-300
K052375
Alilife Technological Co., Ltd.
Physical Medicine · 10d
Cleared Jun 10, 2005
LEVO COMFORT II
K051387
Levo AG
Physical Medicine · 14d
Cleared Jan 26, 2005
LSA HELIUM
K042596
Lifestand
Physical Medicine · 125d

About Product Code IPL - Regulatory Context

510(k) Submission Activity

66 total 510(k) submissions under product code IPL since 1979, with 66 receiving FDA clearance (average review time: 134 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - IPL Product Code

Recent submissions under IPL have taken an average of 93 days to reach a decision - down from 134 days historically, suggesting improved FDA processing for this classification.

IPL devices are reviewed by the Physical Medicine panel. Browse all Physical Medicine devices →