Tek RMD
Tek RMD: 7 catalogue numbers listed by Matia Robotics (US), Inc., United States, under Wheelchair, Standup. 1 manufacturer in China is registered for this product code.
1manufacturer
7catalogue numbers in this listing
1510(k) clearance
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 | Matia Robotics (US), Inc., United States |
|---|---|
| FDA product code | IPL |
| Device type | Wheelchair, Standup |
| Device class | Class 2 |
| Regulation | 21 CFR 890.3900 |
| Establishment | Manufacturer |
| 510(k) | K191334 |
| Record published | 2021-06-07 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02 | In distribution | |
| 04 | In distribution | |
| 06 | In distribution | |
| 03 | In distribution | |
| 07 | In distribution | |
| 08 | In distribution | |
| 05 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Karman Healthcare | Karman Healthcare Inc. | 4 |
| Levo | Levo AG Wohlen | 4 |
| SuperStand Standing Wheelchair | Standing Company, THE | 3 |
| 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191334 | 2020-05-29 |
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.