FDA UDI
In Commercial Distribution
🇺🇸 United States
Tek Robotic Mobilization Device
DI: 00811478030006
·
Model: 01
·
Matia Robotics (us), Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Tek Robotic Mobilization Device
- Primary DI
- 00811478030006
- Version / Model
- 01
- Catalog Number
- TEKRMD01
- Company Name
- Matia Robotics (us), Inc.
- Labeler DUNS
- 080949236
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-03-21
- Public Version
- 2
- Public Version Date
- 2018-07-06
- Public Version Status
- New
- Public Device Record Key
- 4e2b2de0-682e-472e-bde1-2c13c34bf781
Device Description
The Tek RMD (Robotic Mobilization Device) is an electric lift and mobile stander. It brings person from seated position to a passive standing position and have mobility.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| IPL | Wheelchair, Standup | Physical Medicine | 890.3900 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40840 | Wheelchair, electric-motor-driven, attendant/occupant-controlled, powered-steering, collapsible | A wheeled personal mobility device that incorporates a seat-support system for a person with a disability or a person without the full capacity to walk (not bariatric) designed to be propelled by power from one or more electric motor(s). The electronic control of speed and direction may be performed by an attendant or the occupant. The device may be disassembled or folded for transport. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00811478030006 | GS1 |
Customer Contacts
- Phone
- 1.801.997.1812
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K150548 | 000 |