IPL — Wheelchair, Standup Class II
FDA product code IPL covers "Wheelchair, Standup", a Class II medical device regulated under 21 CFR 890.3900. Submissions are reviewed by the Physical Medicine panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IPL
- Device Class
- Class II
- Regulation Number
- 890.3900
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K243783 | shenzhen zuowei technology co | Walking rehabilitation training electric wheelchair (ZW518) | March 12, 2025 |
| K202728 | action manufacturing | Action Trackchair Hawk | February 10, 2022 |
| K203761 | powerbasetec | ParaMotion | January 21, 2022 |
| K191334 | matia robotics (us) | Tek RMD (TEK ROBOTIC MOBILIZATION DEVICE) TEKRMD02, TEKRMD03, TEKRMD04, TEKRMD04 | May 29, 2020 |
| K190682 | permobil | Explorer Mini | February 27, 2020 |
| K191874 | permobil | F5 Corpus VS | October 25, 2019 |
| K182257 | upnride robotics | UPnRIDE | September 12, 2019 |
| K191376 | motion concepts | Modular Power Standing System | August 13, 2019 |
| K172384 | sunrise medical (us) | Quickie(r) Q700-UP M | January 16, 2018 |
| K163451 | action manufacturing | Action Trackstander models TR1816, TR1820, TR2016, and TR2020 | January 12, 2018 |
| K150548 | matia robotics mekatroik sis. ar-ge muh. yaz.san ve tic.a.s | Tek RMD (Tek Robotic Mobilization Device) | June 11, 2015 |
| K122562 | e-teng technology | E-TENG MODEL EOR 1 | August 9, 2013 |
| K102837 | max mobility | HIROLLER ELEVATING WHEELCHAIR | December 23, 2010 |
| K102734 | comfort orthopedic co | COMFORT STANDING WHEELCHAIR, HERO SERIES | December 14, 2010 |
| K090256 | davismade | POWER STANDING DANI | July 6, 2009 |
| K083017 | levo | LEVO C3 | October 24, 2008 |
| K072475 | etac sverige | BALDER FINESSE AND JUNIOR POWERED WHEELCHAIRS (WITH STAND-UP OPTION) | December 21, 2007 |
| K071761 | lloyd linden | LLOYD LINDEN, MODEL E04 | August 3, 2007 |
| K071390 | innovative products | WHEELCHAIR MODEL STS | July 20, 2007 |
| K061726 | lifestand | LSC, MODEL 3 | December 4, 2006 |