SuperStand Standing Wheelchair
Full-power, power to drive and power to stand, standing wheelchair
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Zuowei Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
Record
| Listed by | Standing Company, THE |
|---|---|
| FDA product code | IPL |
| Device type | Wheelchair, Standup |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3900 |
| 510(k) | K032101 |
| Record published | 2016-09-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HPS-2 | In distribution | |
| SS-1F | In distribution | |
| PS-2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Tek RMD | Matia Robotics (US), Inc. | 7 |
| Karman Healthcare | Karman Healthcare Inc. | 4 |
| Levo | Levo AG Wohlen | 4 |
| ParaGolfer Power Wheelchair | Otto Bock Mobility Solutions GmbH | 3 |
| Modular Power Standing System | Motion Concepts | 2 |
| Redman/Chief Power Chair | Chief Power Chair, LLC | 1 |
| SuperStand | Standing Company, THE | 1 |
| ParaGolfer | Otto Bock Mobility Solutions GmbH | 1 |
| Permobil | Permobil, Inc. | 1 |
| Quickie Q700-UP M / Q700M | Sunrise Medical (US) LLC | 1 |
| Tek Robotic Mobilization Device | Matia Robotics (US), Inc. | 1 |
| TEK Robotic Mobilization Device | Matia Robotics Mekatronik Sistemler AR-GE Muhendislik Yazilim Sanayi VE Ticaret A S | 1 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| THE Standing Company | 510(k) number | 0013-05-16 | Class II | Component design/selection | Power Superstand Standing Wheel chair, flex shaft (the flexible wand which supports the joystick control module) may fracture if it is bent repeatedly and /or beyond 90 degrees. A newly designed Flexshaft which corrects this problem is avai | approximately 119 | 2014-06-25 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.