IPL · Wheelchair, Standup
Physical Medicine · 21 CFR 890.3900 · Class 2
Overview
| Product Code | IPL |
|---|---|
| Device Name | Wheelchair, Standup |
| Regulation | 21 CFR 890.3900 |
| Device Class | Class 2 |
| Review Panel | Physical Medicine |
| 3rd-Party Reviewable | Yes |
Identification
A standup wheelchair is a device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. The device incorporates an external manually controlled mechanical system that is intended to raise a paraplegic to an upright position by means of an elevating seat.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 66)
Showing 20 most recent of 66 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K243783 | Walking rehabilitation training electric wheelchair (ZW518) | Shenzhen Zuowei Technology Co., Ltd. | Mar 12, 2025 | SESE |
| K202728 | Action Trackchair Hawk | Action Manufacturing, Inc. | Feb 10, 2022 | SESE |
| K203761 | ParaMotion | Powerbasetec GmbH | Jan 21, 2022 | SESE |
| K191334 | Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04, TEKRMD05, TEKRMD06, TEKRMD07, TEKRMD08 | Matia Robotics (Us), Inc. | May 29, 2020 | SESE |
| K190682 | Explorer Mini | Permobil AB | Feb 27, 2020 | SESE |
| K191874 | F5 Corpus VS | Permobil AB | Oct 25, 2019 | SESE |
| K182257 | UPnRIDE | Upnride Robotics , Ltd. | Sep 12, 2019 | SESE |
| K191376 | Modular Power Standing System | Motion Concepts | Aug 13, 2019 | SESE |
| K172384 | Quickie(r) Q700-UP M | Sunrise Medical (Us), LLC | Jan 16, 2018 | SESE |
| K163451 | Action Trackstander models TR1816, TR1820, TR2016, and TR2020 | Action Manufacturing, Inc. | Jan 12, 2018 | SESE |
| K150548 | Tek RMD (Tek Robotic Mobilization Device) | Matia Robotics Mekatroik Sis. Ar-Ge Muh. Yaz.San VE Tic.A.S | Jun 11, 2015 | SESE |
| K122562 | E-TENG MODEL EOR 1 | E-Teng Technology, Inc. | Aug 9, 2013 | SESE |
| K102837 | HIROLLER ELEVATING WHEELCHAIR | Max Mobility, LLC | Dec 23, 2010 | SESE |
| K102734 | COMFORT STANDING WHEELCHAIR, HERO SERIES | Comfort Orthopedic Co., Ltd. | Dec 14, 2010 | SESE |
| K090256 | POWER STANDING DANI | Davismade, Inc. | Jul 6, 2009 | SESE |
| K083017 | LEVO C3 | Levo AG | Oct 24, 2008 | SESE |
| K072475 | BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION) | Etac Sverige AB | Dec 21, 2007 | SESE |
| K071761 | LLOYD LINDEN, MODEL E04 | Lloyd Linden, Inc. | Aug 3, 2007 | SESE |
| K071390 | WHEELCHAIR MODEL STS | Innovative Products, Inc. | Jul 20, 2007 | SESE |
| K061726 | LSC, MODEL 3 | Lifestand | Dec 4, 2006 | SESE |
Top Applicants
- Levo USA — 4 clearances
- Comfort Orthopedic Co., Ltd. — 3 clearances
- Levo AG — 3 clearances
- Lifestand — 3 clearances
- Action Manufacturing, Inc. — 2 clearances
