FDA UDI
In Commercial Distribution
🇺🇸 United States
Quickie Xtender
DI: 00016958056761
·
Model: Quickie Xtender
·
SUNRISE MEDICAL (US) LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Quickie Xtender
- Primary DI
- 00016958056761
- Version / Model
- Quickie Xtender
- Catalog Number
- EIXT
- Company Name
- SUNRISE MEDICAL (US) LLC
- Labeler DUNS
- 962525056
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-03
- Public Version
- 2
- Public Version Date
- 2023-04-04
- Public Version Status
- Update
- Public Device Record Key
- c4cc90a6-58f5-4cc0-b0ab-ad87dc4e344f
Device Description
The Quickie® Xtender® electric assist wheelchair accessory expands the range of mobility for manual wheelchair users by adding power assisted wheels to a manual frame. The Xtender increases your travel distance and propulsion efficiency and reduces overall fatigue while allowing you to maintain the look, control, and functionality of a manual wheelchair.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- No
- 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 |
|---|---|---|---|---|
| ITI | Wheelchair, Powered | Physical Medicine | 890.3860 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 41875 | Electric-motor-driven wheelchair, occupant-controlled | An electrically-powered wheeled personal mobility device with a seat designed to enable a non-bariatric person with a disability, or without the full capacity to walk, to self-mobilize using power from an electric motor(s). It includes controls (typically joystick) to allow the occupant electronic control of speed/direction; it is not designed with a foot platform and handlebars (i.e., not a mobility scooter). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00016958056761 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K001491 | 000 |