ParaGolfer Power Wheelchair
3 catalogue numbers from 490E54=00000_K, listed by Otto Bock Mobility Solutions GmbH, Germany, under Wheelchair, Standup. 1 manufacturer in China is registered for this product code.
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 | Otto Bock Mobility Solutions GmbH, Germany |
|---|---|
| FDA product code | IPL |
| Device type | Wheelchair, Standup |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3900 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K060936 |
| Record published | 2016-09-15 |
| Record revised | 2023-10-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2022-06-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 490E54=00000_K | Withdrawn | |
| 490E54=00000_X | Withdrawn | |
| 490E54=00000_K | Withdrawn |
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 |
| SuperStand Standing Wheelchair | Standing Company, THE | 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 |
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.